PADCEV^TM Plus KEYTRUDA^TM Significantl… 2025年08月12日 18時30分

PADCEV plus KEYTRUDA is the first and only regimen to improve survival when used before and after standard of care (surgical cystectomy) in cisplatin-ineligible patients with muscle-invasive bladder cancerResults will be discussed with global health authorities for potential regulatory filingsNEW YORK AND TOKYO, August 12, 2025 – Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced positive topline results from the Phase 3 EV-303 clinical trial (also known as KEYNOTE-905). The EV-303 study is evaluating PADCEVTM (enfortumab vedotin), a Nectin-4 directed antibody-drug conjugate, in combination with KEYTRUDATM (pembrolizumab), a PD-1 inhibitor, as neoadjuvant and adjuvant treatment (before and after surgery) versus surgery alone, the current standard of care, in patients with muscle-invasive bladder cancer (MIBC) who are not eligible for or declined cisplatin-based chemotherapy.At the first interim efficacy analysis, the trial demonstrated a clinically meaningful and statistically significant improvement in event-free survival (EFS), the study’s primary endpoint, and overall survival (OS), a key secondary endpoint, with neoadjuvant and adjuvant PADCEV plus KEYTRUDA versus surgery alone. An additional secondary endpoint of pathologic complete response (pCR) rate was also met.Christof Vulsteke, M.D., Ph.D., Head of Integrated Cancer Center Ghent (IKG, Belgium) and Clinical Trial Unit Oncology Ghent and EV-303 principal investigator“Patients with muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy have not seen a significant treatment advance beyond surgery and face high rates of disease recurrence and a poor prognosis, even after having their bladder removed. These EV-303 study results mark the first time a systemic treatment approach, used before and after surgery, significantly extended survival over standard-of-care surgery in this population, demonstrating the potential of this combination to address a critical unmet patient need.”The trial is continuing to evaluate the secondary EFS, OS and pCR rate endpoints for neoadjuvant and adjuvant KEYTRUDA versus surgery alone as they continue to mature. The safety profiles for PADCEV plus KEYTRUDA and KEYTRUDA monotherapy were consistent with the known profiles of each treatment regimen.Moitreyee Chatterjee-Kishore, Ph.D., M.B.A., Head of Oncology Development, Astellas“These results from EV-303 represent a breakthrough for cisplatin-ineligible patients with muscle-invasive bladder cancer, demonstrating the potential of PADCEV in combination with KEYTRUDA when used before and after surgery as a new standard of care. We look forward to presenting further details on these data at an upcoming medical congress.”Bladder cancer is the ninth most common cancer worldwide, diagnosed in more than 614,000 patients each year globally.i MIBC represents approximately 30% of all bladder cancer cases.ii The standard treatment for patients with MIBC is neoadjuvant cisplatin-based chemotherapy followed by surgery, which has been shown to prolong survival.ii However, up to half of patients with MIBC are not eligible to receive cisplatin and face limited treatment options, typically undergoing surgery alone.iiiJohanna Bendell, M.D., Oncology Chief Development Officer, Pfizer“PADCEV plus KEYTRUDA has already changed the treatment paradigm for patients with locally advanced or metastatic urothelial cancer as standard of care. These latest results underscore the practice-changing potential of this combination in earlier stages of bladder cancer, where it has the potential to improve outcomes for even more patients. Thank you to the patients and investigators who participated in this trial.”Results will be submitted for presentation at an upcoming medical congress and will be discussed with global health authorities for potential regulatory filings. Neoadjuvant and adjuvant PADCEV plus KEYTRUDA is also being evaluated in cisplatin-eligible patients with MIBC in the EV-304 Phase 3 clinical trial (also known as KEYNOTE-B15).+++About the EV-303 TrialThe EV-303 trial is an ongoing, open-label, randomized, three-arm, controlled, Phase 3 study evaluating neoadjuvant and adjuvant PADCEV in combination with KEYTRUDA or neoadjuvant and adjuvant KEYTRUDA versus surgery alone in patients with MIBC who are either not eligible for or declined cisplatin-based chemotherapy. Patients were randomized to receive either neoadjuvant and adjuvant KEYTRUDA (arm A), surgery alone (arm B) or neoadjuvant and adjuvant PADCEV in combination with KEYTRUDA (arm C).ivThe primary endpoint of this trial is EFS between arm C versus arm B, defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes radical cystectomy (RC) surgery or failure to undergo RC surgery in participants with residual disease, gross residual disease left behind at the time of surgery, local or distant recurrence as assessed by imaging and/or biopsy or death due to any cause. Key secondary endpoints include OS and pCR rate between arm C and arm B, as well as EFS, OS and pCR rate between arm A and arm B.ivFor more information on the global EV-303 trial, go to clinicaltrials.gov.About PADCEVTM (enfortumab vedotin)PADCEVTM (enfortumab vedotin) is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.v Nonclinical data suggest the anticancer activity of PADCEV is due to its binding to Nectin-4-expressing cells, followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).viPADCEV plus KEYTRUDA is approved for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) regardless of cisplatin eligibility in the United States, the European Union, Japan and a number of other countries around the world. PADCEV is also approved as a single agent for the treatment of adult patients with la/mUC who have previously received a PD-1/PD-L1 inhibitor and platinum-containing chemotherapy or are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.viPADCEV® (enfortumab vedotin-ejfv) U.S. Indication & Important Safety InformationBOXED WARNING: SERIOUS SKIN REACTIONSPADCEV can cause severe and fatal cutaneous adverse reactions including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), which occurred predominantly during the first cycle of treatment, but may occur later.Closely monitor patients for skin reactions.Immediately withhold PADCEV and consider referral for specialized care for suspected SJS or TEN or severe skin reactions.Permanently discontinue PADCEV in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions.IndicationPADCEV®, in combination with pembrolizumab, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC).PADCEV, as a single agent, is indicated for the treatment of adult patients with locally advanced or mUC who:have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and platinum-containing chemotherapy, orare ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.PADCEV Important Safety InformationWarnings and PrecautionsSkin reactions Severe cutaneous adverse reactions, including fatal cases of SJS or TEN occurred in patients treated with PADCEV. SJS and TEN occurred predominantly during the first cycle of treatment but may occur later. Skin reactions occurred in 70% (all grades) of the 564 patients treated with PADCEV in combination with pembrolizumab in clinical trials. When PADCEV was given in combination with pembrolizumab, the incidence of skin reactions, including severe events, occurred at a higher rate compared to PADCEV as a single agent. The majority of the skin reactions that occurred with combination therapy included maculo-papular rash, macular rash and papular rash. Grade 3-4 skin reactions occurred in 17% of patients (Grade 3: 16%, Grade 4: 1%), including maculo-papular rash, bullous dermatitis, dermatitis, exfoliative dermatitis, pemphigoid, rash, erythematous rash, macular rash, and papular rash. A fatal reaction of bullous dermatitis occurred in one patient (0.2%). The median time to onset of severe skin reactions was 1.7 months (range: 0.1 to 17.2 months). Skin reactions led to discontinuation of PADCEV in 6% of patients.Skin reactions occurred in 58% (all grades) of the 720 patients treated with PADCEV as a single agent in clinical trials. Twenty-three percent (23%) of patients had maculo-papular rash and 34% had pruritus. Grade 3-4 skin reactions occurred in 14% of patients, including maculo-papular rash, erythematous rash, rash or drug eruption, symmetrical drug-related intertriginous and flexural exanthema (SDRIFE), bullous dermatitis, exfoliative dermatitis, and palmar-plantar erythrodysesthesia. The median time to onset of severe skin reactions was 0.6 months (range: 0.1 to 8 months). Among patients experiencing a skin reaction leading to dose interruption who then restarted PADCEV (n=75), 24% of patients restarting at the same dose and 24% of patients restarting at a reduced dose experienced recurrent severe skin reactions. Skin reactions led to discontinuation of PADCEV in 3.1% of patients.Monitor patients closely throughout treatment for skin reactions. Consider topical corticosteroids and antihistamines, as clinically indicated. For persistent or recurrent Grade 2 skin reactions, consider withholding PADCEV until Grade ≤1. Withhold PADCEV and refer for specialized care for suspected SJS, TEN or for Grade 3 skin reactions. Permanently discontinue PADCEV in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions.Hyperglycemia and diabetic ketoacidosis (DKA), including fatal events, occurred in patients with and without pre-existing diabetes mellitus, treated with PADCEV. Patients with baseline hemoglobin A1C ≥8% were excluded from clinical trials. In clinical trials of PADCEV as a single agent, 17% of the 720 patients treated with PADCEV developed hyperglycemia of any grade; 7% of patients developed Grade 3-4 hyperglycemia (Grade 3: 6.5%, Grade 4: 0.6%). Fatal events of hyperglycemia and DKA occurred in one patient each (0.1%). The incidence of Grade 3-4 hyperglycemia increased consistently in patients with higher body mass index and in patients with higher baseline A1C. The median time to onset of hyperglycemia was 0.5 months (range: 0 to 20 months). Hyperglycemia led to discontinuation of PADCEV in 0.7% of patients. Five percent (5%) of patients required initiation of insulin therapy for treatment of hyperglycemia. Of the patients who initiated insulin therapy for treatment of hyperglycemia, 66% (23/35) discontinued insulin at the time of last evaluation. Closely monitor blood glucose levels in patients with, or at risk for, diabetes mellitus or hyperglycemia. If blood glucose is elevated (>250 mg/dL), withhold PADCEV.Pneumonitis/Interstitial Lung Disease (ILD) Severe, life-threatening or fatal pneumonitis/ILD occurred in patients treated with PADCEV. When PADCEV was given in combination with pembrolizumab, 10% of the 564 patients treated with combination therapy had pneumonitis/ILD of any grade and 4% had Grade 3-4. A fatal event of pneumonitis/ILD occurred in two patients (0.4%). The incidence of pneumonitis/ILD, including severe events, occurred at a higher rate when PADCEV was given in combination with pembrolizumab compared to PADCEV as a single agent. The median time to onset of any grade pneumonitis/ILD was 4 months (range: 0.3 to 26 months).In clinical trials of PADCEV as a single agent, 3% of the 720 patients treated with PADCEV had pneumonitis/ILD of any grade and 0.8% had Grade 3-4. The median time to onset of any grade pneumonitis/ILD was 2.9 months (range: 0.6 to 6 months).Monitor patients for signs and symptoms indicative of pneumonitis/ILD such as hypoxia, cough, dyspnea or interstitial infiltrates on radiologic exams. Evaluate and exclude infectious, neoplastic and other causes for such signs and symptoms through appropriate investigations. Withhold PADCEV for patients who develop Grade 2 pneumonitis/ILD and consider dose reduction. Permanently discontinue PADCEV in all patients with Grade 3 or 4 pneumonitis/ILD.Peripheral neuropathy (PN) When PADCEV was given in combination with pembrolizumab, 67% of the 564 patients treated with combination therapy had PN of any grade, 36% had Grade 2 neuropathy, and 7% had Grade 3 neuropathy. The incidence of PN occurred at a higher rate when PADCEV was given in combination with pembrolizumab compared to PADCEV as a single agent. The median time to onset of Grade ≥2 PN was 6 months (range: 0.3 to 25 months).PN occurred in 53% of the 720 patients treated with PADCEV as a single agent in clinical trials including 38% with sensory neuropathy, 8% with muscular weakness and 7% with motor neuropathy. Thirty percent of patients experienced Grade 2 reactions and 5% experienced Grade 3-4 reactions. PN occurred in patients treated with PADCEV with or without preexisting PN. The median time to onset of Grade ≥2 PN was 4.9 months (range: 0.1 to 20 months). Neuropathy led to treatment discontinuation in 6% of patients.Monitor patients for symptoms of new or worsening PN and consider dose interruption or dose reduction of PADCEV when PN occurs. Permanently discontinue PADCEV in patients who develop Grade ≥3 PN.Ocular disorders were reported in 40% of the 384 patients treated with PADCEV as a single agent in clinical trials in which ophthalmologic exams were scheduled. The majority of these events involved the cornea and included events associated with dry eye such as keratitis, blurred vision, increased lacrimation, conjunctivitis, limbal stem cell deficiency, and keratopathy. Dry eye symptoms occurred in 30% of patients, and blurred vision occurred in 10% of patients, during treatment with PADCEV. The median time to onset to symptomatic ocular disorder was 1.7 months (range: 0 to 30.6 months). Monitor patients for ocular disorders. Consider artificial tears for prophylaxis of dry eyes and ophthalmologic evaluation if ocular symptoms occur or do not resolve. Consider treatment with ophthalmic topical steroids, if indicated after an ophthalmic exam. Consider dose interruption or dose reduction of PADCEV for symptomatic ocular disorders.Infusion site extravasation Skin and soft tissue reactions secondary to extravasation have been observed after administration of PADCEV. Of the 720 patients treated with PADCEV as a single agent in clinical trials, 1% of patients experienced skin and soft tissue reactions, including 0.3% who experienced Grade 3-4 reactions. Reactions may be delayed. Erythema, swelling, increased temperature, and pain worsened until 2-7 days after extravasation and resolved within 1-4 weeks of peak. Two patients (0.3%) developed extravasation reactions with secondary cellulitis, bullae, or exfoliation. Ensure adequate venous access prior to starting PADCEV and monitor for possible extravasation during administration. If extravasation occurs, stop the infusion and monitor for adverse reactions.Embryo-fetal toxicity PADCEV can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to the fetus. Advise female patients of reproductive potential to use effective contraception during PADCEV treatment and for 2 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with PADCEV and for 4 months after the last dose.ADVERSE REACTIONSMost common adverse reactions, including laboratory abnormalities (≥20%) (PADCEV in combination with pembrolizumab)Increased aspartate aminotransferase (AST), increased creatinine, rash, increased glucose, PN, increased lipase, decreased lymphocytes, increased alanine aminotransferase (ALT), decreased hemoglobin, fatigue, decreased sodium, decreased phosphate, decreased albumin, pruritus, diarrhea, alopecia, decreased weight, decreased appetite, increased urate, decreased neutrophils, decreased potassium, dry eye, nausea, constipation, increased potassium, dysgeusia, urinary tract infection and decreased platelets.Most common adverse reactions, including laboratory abnormalities (≥20%) (PADCEV monotherapy)Increased glucose, increased AST, decreased lymphocytes, increased creatinine, rash, fatigue, PN, decreased albumin, decreased hemoglobin, alopecia, decreased appetite, decreased neutrophils, decreased sodium, increased ALT, decreased phosphate, diarrhea, nausea, pruritus, increased urate, dry eye, dysgeusia, constipation, increased lipase, decreased weight, decreased platelets, abdominal pain, dry skin.EV-302 Study: 440 patients with previously untreated la/mUC (PADCEV in combination with pembrolizumab)Serious adverse reactions occurred in 50% of patients treated with PADCEV in combination with pembrolizumab. The most common serious adverse reactions (≥2%) were rash (6%), acute kidney injury (5%), pneumonitis/ILD (4.5%), urinary tract infection (3.6%), diarrhea (3.2%), pneumonia (2.3%), pyrexia (2%), and hyperglycemia (2%). Fatal adverse reactions occurred in 3.9% of patients treated with PADCEV in combination with pembrolizumab including acute respiratory failure (0.7%), pneumonia (0.5%), and pneumonitis/ILD (0.2%).Adverse reactions leading to discontinuation of PADCEV occurred in 35% of patients. The most common adverse reactions (≥2%) leading to discontinuation of PADCEV were PN (15%), rash (4.1%) and pneumonitis/ILD (2.3%). Adverse reactions leading to dose interruption of PADCEV occurred in 73% of patients. The most common adverse reactions (≥2%) leading to dose interruption of PADCEV were PN (22%), rash (16%), COVID‑19 (10%), diarrhea (5%), pneumonitis/ILD (4.8%), fatigue (3.9%), hyperglycemia (3.6%), increased ALT (3%) and pruritus (2.5%). Adverse reactions leading to dose reduction of PADCEV occurred in 42% of patients. The most common adverse reactions (≥2%) leading to dose reduction of PADCEV were rash (16%), PN (13%) and fatigue (2.7%).EV-103 Study: 121 patients with previously untreated la/mUC who were not eligible for cisplatin-containing chemotherapy (PADCEV in combination with pembrolizumab)Serious adverse reactions occurred in 50% of patients treated with PADCEV in combination with pembrolizumab; the most common (≥2%) were acute kidney injury (7%), urinary tract infection (7%), urosepsis (5%), sepsis (3.3%), pneumonia (3.3%), hematuria (3.3%), pneumonitis/ILD (3.3%), urinary retention (2.5%), diarrhea (2.5%), myasthenia gravis (2.5%), myositis (2.5%), anemia (2.5%), and hypotension (2.5%). Fatal adverse reactions occurred in 5% of patients treated with PADCEV in combination with pembrolizumab, including sepsis (1.6%), bullous dermatitis (0.8%), myasthenia gravis (0.8%), and pneumonitis/ILD (0.8%). Adverse reactions leading to discontinuation of PADCEV occurred in 36% of patients; the most common (≥2%) were PN (20%) and rash (6%). Adverse reactions leading to dose interruption of PADCEV occurred in 69% of patients; the most common (≥2%) were PN (18%), rash (12%), increased lipase (6%), pneumonitis/ILD (6%), diarrhea (4.1%), acute kidney injury (3.3%), increased ALT (3.3%), fatigue (3.3%), neutropenia (3.3%), urinary tract infection (3.3%), increased amylase (2.5%), anemia (2.5%), COVID‑19 (2.5%), hyperglycemia (2.5%), and hypotension (2.5%). Adverse reactions leading to dose reduction of PADCEV occurred in 45% of patients; the most common (≥2%) were PN (17%), rash (12%), fatigue (5%), neutropenia (5%), and diarrhea (4.1%).EV-301 Study: 296 patients previously treated with a PD-1/L1 inhibitor and platinum-based chemotherapy (PADCEV monotherapy)Serious adverse reactions occurred in 47% of patients treated with PADCEV; the most common (≥2%) were urinary tract infection, acute kidney injury (7% each), and pneumonia (5%). Fatal adverse reactions occurred in 3% of patients, including multiorgan dysfunction (1%), hepatic dysfunction, septic shock, hyperglycemia, pneumonitis/ILD, and pelvic abscess (0.3% each). Adverse reactions leading to discontinuation occurred in 17% of patients; the most common (≥2%) were PN (5%) and rash (4%). Adverse reactions leading to dose interruption occurred in 61% of patients; the most common (≥4%) were PN (23%), rash (11%), and fatigue (9%). Adverse reactions leading to dose reduction occurred in 34% of patients; the most common (≥2%) were PN (10%), rash (8%), decreased appetite, and fatigue (3% each).EV-201, Cohort 2 Study: 89 patients previously treated with a PD-1/L1 inhibitor and not eligible for cisplatin-based chemotherapy (PADCEV monotherapy)Serious adverse reactions occurred in 39% of patients treated with PADCEV; the most common (≥3%) were pneumonia, sepsis, and diarrhea (5% each). Fatal adverse reactions occurred in 8% of patients, including acute kidney injury (2.2%), metabolic acidosis, sepsis, multiorgan dysfunction, pneumonia, and pneumonitis/ILD (1.1% each). Adverse reactions leading to discontinuation occurred in 20% of patients; the most common (≥2%) was PN (7%). Adverse reactions leading to dose interruption occurred in 60% of patients; the most common (≥3%) were PN (19%), rash (9%), fatigue (8%), diarrhea (5%), increased AST, and hyperglycemia (3% each). Adverse reactions leading to dose reduction occurred in 49% of patients; the most common (≥3%) were PN (19%), rash (11%), and fatigue (7%).DRUG INTERACTIONSEffects of other drugs on PADCEV (Dual P-gp and Strong CYP3A4 Inhibitors)Concomitant use with dual P-gp and strong CYP3A4 inhibitors may increase unconjugated monomethyl auristatin E exposure, which may increase the incidence or severity of PADCEV toxicities. Closely monitor patients for signs of toxicity when PADCEV is given concomitantly with dual P-gp and strong CYP3A4 inhibitors.SPECIFIC POPULATIONSLactation Advise lactating women not to breastfeed during treatment with PADCEV and for 3 weeks after the last dose.Hepatic impairment Avoid the use of PADCEV in patients with moderate or severe hepatic impairment.For more information, please see the U.S. full Prescribing Information including BOXED WARNING for PADCEV here.About AstellasAstellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com.About Pfizer OncologyAt Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and bispecific antibodies, including other immune-oncology biologics. We are focused on delivering transformative therapies in some of the world’s most common cancers, including breast cancer, genitourinary cancer, hematology-oncology, and thoracic cancers, which includes lung cancer. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives.About the Pfizer, Astellas and Merck CollaborationSeagen and Astellas previously entered a clinical collaboration agreement with Merck to evaluate the combination of Seagen’s and Astellas’ PADCEVTM (enfortumab vedotin) and Merck’s KEYTRUDATM (pembrolizumab) in patients with muscle-invasive bladder cancer (MIBC) who are not eligible for or declined cisplatin-based chemotherapy. Pfizer Inc. successfully completed its acquisition of Seagen on December 14, 2023. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the United States and Canada).Astellas Cautionary NotesIn this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.Pfizer Disclosure NoticeThe information contained in this release is as of August 12, 2025. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.This release contains forward-looking information about Pfizer Oncology and PADCEVTM (enfortumab vedotin) in combination with pembrolizumab in cisplatin-ineligible patients with muscle-invasive bladder cancer, including their potential benefits, and plans to submit results from the Phase 3 EV-303 clinical trial for presentation at an upcoming medical congress and to share the Phase 3 EV-303 clinical trial results with the appropriate regulatory authorities to explore potential regulatory filings that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risk and uncertainties include, among other things, uncertainties regarding the commercial success of PADCEV; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any applications may be filed with regulatory authorities in particular jurisdictions for any potential indication for PADCEV with pembrolizumab or as a single agent; whether and when any applications that may be pending or filed for PADCEV with pembrolizumab or as a single agent may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether PADCEV with pembrolizumab or as a single agent will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of PADCEV with pembrolizumab or as a single agent; whether the collaboration between Pfizer, Astellas and Merck will be successful; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws or regulations; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.+++i World Bladder Cancer Patient Coalition. GLOBOCAN 2022: Bladder cancer 9th most common worldwide. Accessed June 23, 2025. Available at: https://worldbladdercancer.org/news_events/globocan-2022-bladder-cancer-is-the-9th-most-commonly-diagnosed-worldwide/ii Bladder Cancer Awareness Network. What is Muscle Invasive Bladder Cancer? Accessed June 23, 2025. Available at: https://bcan.org/what-is-muscle-invasive-bladder-cancer/#:~:text=When%20tumors%20grow%20into%20or,Virginia%20Health%20System%20explain%20MIBC. iii Esteban-Villarrubia J, Torres-Jiménez J, Bueno-Bravo C, García-Mondaray R, Subiela JD, Gajate P. Current and Future Landscape of Perioperative Treatment for Muscle-Invasive Bladder Cancer. Cancers (Basel). 2023 Jan 17;15(3):566. doi: 10.3390/cancers15030566. PMID: 36765525; PMCID: PMC9913718.iv National Institute of Health. National Library of Medicine. Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303. ClinicalTrials.gov identifier: NCT03924895. Published July 24, 2019. Updated June 17, 2025. Accessed June 23, 2025. Available at: https://clinicaltrials.gov/study/NCT03924895?term=AREA%5BBasicSearch%5D(myosarcoma)&rank=3v Challita-Eid PM, Satpayev D, Yang P, et al. Enfortumab vedotin antibody-drug conjugate targeting nectin-4 is a highly potent therapeutic agent in multiple preclinical cancer models. Cancer Res 2016;76(10):3003-13.vi PADCEV [package insert]. Northbrook, IL: Astellas Pharma US, Inc. Click below for a copy of the full press release 

Posted Financial Results for Q1 YTD/FY2025 2025年07月30日 15時30分

Astellas Announces a Partnership with the “Korea Institute … 2025年07月17日 13時00分

- Supporting Korean Startups’ Drug Discovery Research and Global Expansion -- First Pharmaceutical Company from Japan to Actively Support the Operation of the Program -TOKYO, July 17, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that it has agreed on a memorandum of understanding (“MoU”) with the Korea Institute of Startup and Entrepreneurship Development (President: Jong-pil Yoo, “KISED”), an umbrella organization of the Ministry of SMEs and Startups, a Korean Government Agency, for the operation of the Partnership with Global Companies Program, which aims to identify Korean drug-discovery startups and support their business growth and global expansion.Under the terms of the MoU, KISED will provide overall management and research funding for the Partnership with Global Companies Program. Astellas will provide Korean drug-discovery startups, which are selected together, with KISED with access to laboratory and office space at SakuLabTM-Tsukuba, located on the premises of the Astellas Tsukuba Research Center. Startups residing in SakuLabTM-Tsukuba will not only receive support through consultations with Astellas experts in various fields, but will also be able to accelerate their drug discovery research by leveraging networks with fellow residents and Astellas researchers.Through this program, two Korean pharmaceutical and biotech startups—TCUBEiT Inc. (a next-generation T-cell-based immunotherapy developer) and AAVATAR Therapeutics (specializing in AAV viral vector engineering technology)—have been selected. They will begin full-scale collaboration by moving into SakuLab™-Tsukuba.Tadaaki Taniguchi, M.D., Ph.D., Chief Research & Development Officer (CRDO) of Astellas“We are very pleased to agree on a MoU with KISED for the Operation of the Partnership with Global Companies Program. In today's world, where new drug discovery ideas and technologies are emerging one after another, Diverse perspectives, expertise and experiences are essential to turning innovative ideas and technologies into VALUE for patients. Astellas is committed to fostering innovation in collaboration with startups by providing knowledge and expertise we have gained through our research and global network. We expect that the signing of this MoU will further strengthen and accelerate drug discovery research together with Korean startups, ultimately contributing to the creation of innovative medical solutions.”Jong-pil Yoo, President of KISED“This agreement will serve as a significant opportunity to accelerate the global expansion of promising Korean startups in the bio and pharmaceutical sectors through strategic collaboration with Astellas, a global pharmaceutical company. In particular, as new drug development requires a high level of expertise and infrastructure, this program—enabling startups to leverage Astellas' research assets and global network directly—is expected to provide substantial support for their growth. KISED will continue to strengthen its partnerships with global corporations to ensure that Korean startups can enhance their competitiveness in the global market.”The impact of this partnership on Astellas’ financial results for the fiscal year ending March 31, 2026, is expected to be minor.About AstellasAstellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com.About Ministry of SMEs and StartupsThe Ministry of SMEs and Startups is a central government agency in South Korea, dedicated to enhancing the competitiveness and fostering innovation among small and medium-sized enterprises (SMEs) and venture businesses. Initially established in 1996 as the Ministry of SMEs, it was rebranded in 2017 as the Ministry of SMEs and Startups to more accurately reflect its expanded focus and objectives.MSS is committed to developing and implementing policies that support startup growth, promote corporate development, and strengthen the competitiveness of small businesses within the national and global markets. Learn more at https://www.mss.go.kr/site/eng/main.doAbout KISEDKISED carries out strategic initiatives aimed at advancing the startup ecosystem, enabling tailored and successful startups, securing sustainable future growth engines, and realizing creative and innovative smart management. Learn more at https://www.kised.or.kr/index.es?sid=a2Cautionary Notes (Astellas)In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. Click below for a copy of the full press release 

Sales of IZERVAY™ (Preliminary Figures) 2025年07月10日 08時30分

TOKYO, July 10, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the sales in the U.S. of the IZERVAY™ (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) in the first quarter of FY2025 (April 1, 2025 – June 30, 2025) was ¥15.9 billion/ $110 million (preliminary figures).This information has been disclosed in conjunction with today's meeting for the investment community. Astellas’ financial results for the first quarter of FY2025, including IZERVAY’s sales, will be disclosed and explained at Astellas’ Q1 earnings call scheduled on July 30, 2025.About AstellasAstellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com.Cautionary NotesIn this press release, statements made concerning current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs considering the information currently available to it and involve known and unknown risks and uncertainties. Several factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties.Information about pharmaceutical products (including products currently in development) included in this press release is not intended to constitute an advertisement or medical advice. Click below for a copy of the full press release 

Mitsubishi Research Institute and Astellas Announce Collabo… 2025年06月13日 14時00分

Tokyo, 13 June 2025—Mitsubishi Research Institute, Inc. (“MRI”) and Astellas Pharma Inc. (“Astellas”) today announced that they have agreed on a memorandum of understanding to provide drug-discovery startups in Japan with support in their efforts to go global. The pair aims to strengthen Japan’s position as a global hub for drug discovery and foster the growth of its startups that can thrive globally.The new support represents multiple programs under the Ministry of Health, Labour and Welfare’s Medical Innovation Support Office (MEDISO), which looks to address the lack of practical application of Japan’s advanced life-sciences technologies. Mitsubishi Research Institute has been entrusted to operate MEDISO since 2018 and has been helping promising drug-discovery startups commercialize their intellectual property since.“When it comes to practical application, drug-discovery startups need external insights and expertise,” said Hirofumi Suzuki, Executive Officer and General Manager of the Public Innovation Unit at Mitsubishi Research Institute. “Promising startups can substantially speed up the commercialization of their offerings by engaging with globally active pharmaceutical companies early.”The new partnership looks to leverage the strengths of both companies. MRI will draw from its previous MEDISO work—supporting over twelve hundred startup and academic ventures—and design specific support programs for participants. Astellas Pharma will provide drug-discovery startups participating in the acceleration program conducted through MEDISO with access to laboratory and office space at SakuLabTM -Tsukuba, located on the premises of the Astellas Tsukuba Research Center. Startups residing in SakuLabTM-Tsukuba will not only receive support through consultations with Astellas experts in various fields, but will also be able to accelerate their drug discovery research by leveraging networks with fellow residents and Astellas researchers.“We are very pleased to agree on a memorandum of understanding with MRI. Astellas Pharma is committed to growing and developing innovative ideas and technologies with academia and startups by providing knowledge and experience gained through research and our global network,” said Tadaaki Taniguchi, M.D., Ph.D., Chief Research & Development Officer (CRDO) of Astellas Pharma. “We expect that the signing of this MoU will further strengthen and accelerate drug discovery research by Japanese startups, ultimately leading to the creation of innovative medical solutions.”The new support will provide Japanese drug-discovery startups with early access to pharmaceutical-industry insights, enabling them to chart a path toward successful global development and potential out-licensing. This aligns with the Basic Policy on Economic and Fiscal Management and Reform 2024, which aims to improve domestic research and development environments while encouraging the participation of global pharmaceutical companies and venture capitalists in building a robust drug discovery ecosystem.“We are pleased to partner with Astellas Pharma to support startups under the MEDISO initiative, and we are sure that this will be a groundbreaking step for Japan’s drug discovery ecosystem,” said Suzuki. “We are committed to leveraging the strengths of both companies to swiftly deliver innovative pharmaceuticals to patients in Japan and globally.”Moving forward, MEDISO as a whole aims to collaborate with domestic and international business partners to support the global expansion of Japanese drug- discovery startups while encouraging global investors to invest in Japan’s burgeoning drug discovery field.About Mitsubishi Research Institute, Inc.Mitsubishi Research Institute is one of Japan’s foremost think tanks. For over five decades, it has provided the public and private sectors with research and consulting services in fields spanning healthcare, the environment, energy, and digital transformation. This is accompanied by policy recommendations and the real-world application of solutions. Mitsubishi Research Institute will continue to envision the future, resolve societal issues, and lead change to build a sustainable and prosperous world. For more information, please visit: www.mri.co.jp/en/About Astellas Pharma Inc.Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com. Click below for a copy of the full press release 

Astellas Enters Exclusive License Agreement with Evopoint B… 2025年05月30日 08時45分

- Agreement grants Astellas exclusive worldwide rights (excluding China’s mainland, Hong Kong, Macao and Taiwan region) to develop and commercialize XNW27011 -- XNW27011 has demonstrated encouraging monotherapy efficacy in an ongoing Phase 1/2 study of patients with solid tumors, including gastric cancer, gastroesophageal cancer and pancreatic cancer -- Evopoint to receive a $130 million upfront payment and is eligible to receive up to $70 million near-term payments, and additional milestone payments associated with development, regulatory and commercialization milestones totaling up to $1.34 billion, as well as royalties on net sales of XNW27011, if approved -TOKYO, Japan and SUZHOU, China, May 30, 2025, Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Evopoint Biosciences (Evopoint Biosciences Co., Ltd.) today announced they have entered into an exclusive license agreement for XNW27011, a novel investigational clinical-stage antibody-drug conjugate (ADC) targeting CLDN18.2. The agreement grants Astellas a worldwide (excluding China’s mainland, Hong Kong, Macao and Taiwan region) exclusive license to develop and commercialize XNW27011.XNW27011 is currently being evaluated in a Phase 1/2 study in China in patients with CLDN18.2-expressing solid tumors, including gastric cancer, gastroesophageal cancer and pancreatic cancer. It uses a proprietary topoisomerase I inhibitor payload and linker technology, an approach that has demonstrated clinical success in other approved cancer therapies.Astellas has significant expertise in developing therapies that target CLDN18.2, including VYLOYTM, the first CLDN18.2-targeted therapy approved in the world. XNW27011 has the potential to address currently unmet patient need and will expand Astellas’ oncology pipeline which currently contains CLDN-targeting therapies utilizing different approaches, as well as ADC’s directed to other targets.Under the terms of the agreement, Evopoint will receive a $130 million upfront payment and is eligible to receive up to $70 million near-term payments, and additional milestone payments associated with development, regulatory and commercialization milestones totaling up to $1.34 billion, as well as royalties on net sales of XNW27011, if approved.Adam Pearson, Chief Strategy Officer, Astellas“Astellas is dedicated to advancing innovative therapies for some of the most challenging-to-treat cancers, such as gastric and pancreatic cancer. XNW27011 is a promising new asset that complements Astellas’ pipeline and enhances our leading position in precision oncology. We look forward to harnessing our expertise in targeting CLDN18.2 and specialized knowledge in GI cancers to advance XNW27011 and deliver meaningful outcomes to patients.”Arthur Qiang, Chairman, Evopoint“XNW27011 is a novel investigational antibody-drug conjugate that has shown great promise in the clinic. Astellas has a proven history of developing and commercializing a strong franchise of innovative cancer therapies. We are pleased to enter into this new license agreement to further our collective goals of bringing new treatment options for patients in need worldwide.”About AstellasAstellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com. About Evopoint BiosciencesEvopoint Biosciences is an innovative biopharmaceutical company with exceptional capabilities in R&D and commercialization. Since its inception, Evopoint has been committed to improving human health by discovering and developing cutting-edge pharmaceutical solutions that address significant unmet medical needs worldwide.  Leveraging diverse discovery platforms in targeted therapy, ADC, and targeted protein degradation (TPD), the company has built a robust pipeline focused on oncology, infectious diseases and metabolic diseases. Learn more at www.evopointbio.com.Astellas Cautionary NotesIn this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. Click below for a copy of the full press release 

Posted Notice of Convocation of the 20th Term Annual Shareh… 2025年05月27日 13時00分

Shaping the Future with Pompe Patients 2025年05月27日 10時00分

Astellas and Pfizer’s XTANDI™ (enzalutamide) Shows Long-Ter… 2025年05月23日 09時00分

Five-year follow-up data from the Phase 3 ARCHES trial shows XTANDI (enzalutamide) plus androgen deprivation therapy (ADT) reduces risk of death by 30%After a median follow-up of 61.4 months, treatment with (XTANDI) enzalutamide plus ADT was associated with a 66% probability of survival at five years compared to 53% probability of survival with placebo plus ADTXTANDI (enzalutamide) is the first and only androgen receptor inhibitor to demonstrate an overall survival benefit at five years in men with metastatic hormone-sensitive prostate cancerData continue to show wide-ranging effect of treatment with XTANDI (enzalutamide) plus ADT across various patient subgroups, notably those with high-volume disease, no prior docetaxel use, and synchronous diseaseLong-term data reinforce XTANDI (enzalutamide) plus ADT as a standard of care TOKYO and NEW YORK, May 22, 2025 — Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Pfizer Inc. (NYSE: PFE) today announced longer-term follow-up results from an open-label extension of the Phase 3 ARCHES (NCT02677896) study, reporting a five-year follow up of overall survival (OS) benefits and a 30% reduction in the risk of death in men with metastatic hormone-sensitive prostate cancer (mHSPC) treated with XTANDI™ (enzalutamide), an androgen receptor pathway inhibitor (ARPI), plus androgen deprivation therapy (ADT) compared to placebo plus ADT. These data will be presented during an oral presentation (Abstract #5005) at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (Tuesday, June 3, 9:45 a.m.- 12:45 p.m. US CT).“Historically, the likelihood of survival at five years for men with metastatic hormone-sensitive prostate cancer was low, but with advancements in initial treatment intensification like what we’ve seen with XTANDI, this is now becoming the standard,” said Andrew J. Armstrong, MD, ScM, Director of Research at the Center for Prostate & Urologic Cancers, Duke Cancer Institute, Durham, NC, and ARCHES primary investigator. “In our five-year follow up of the global ARCHES trial, two-thirds of men are now surviving five years, representing a 13% absolute and 30% relative improvement over standard hormonal therapy alone, with benefits in patients with high and low disease burden that are meaningful to our patients.”In patients with high-volume disease (HR: 0.70; 95% CI: 0.56-0.88) a 36-month improvement in median OS was observed. Additional clinically relevant subgroups of patients were evaluated, showing consistently improved survival: low-volume disease (HR: 0.71; 95% CI, 0.49-1.05); patients who had previously received docetaxel therapy (HR: 0.67; 95% CI, 0.43- 1.05) and those who had not received prior docetaxel therapy (HR: 0.71; 95% CI, 0.57-0.88). The incidence of treatment-emergent adverse events in the five-year follow-up is consistent with prior ARCHES analyses and no new safety signals were identified.“The survival benefits of intervention with XTANDI in advanced prostate cancer are well-recognized,” added Shontelle Dodson, Executive Vice President, Head of Medical Affairs, Astellas. “The collective – and growing – body of data for XTANDI continues to reinforce its long-term efficacy and patient impact in prostate cancer, including in the metastatic setting, and shows that XTANDI is changing the trajectory of those living with the disease.”These results of the five-year follow-up from the ARCHES study will be submitted for publication in a peer-reviewed journal in the near future.“Until recently, patients with metastatic hormone-sensitive prostate cancer faced a poor prognosis, particularly in advanced stages, often due to treatment resistance,” said Johanna Bendell, M.D., Oncology Chief Development Officer, Pfizer. “As the only androgen receptor inhibitor demonstrating sustained five-year survival in this patient population, these data further reinforce XTANDI combined with androgen deprivation therapy as the standard-of-care for treating this advanced disease.”In addition to five-year data from the follow-up ARCHES study, eight-year data from the ENZAMET study assessing outcomes of enzalutamide versus non-steroidal anti-androgen (NSAA) – both plus testosterone suppression with or without docetaxel – in mHSPC will also be presented during a poster session at ASCO (Monday, June 2, 9:00 a.m. US CT). This independent, Phase 3 trial sponsored by the University of Sydney (NCT02446405), led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group Limited (ANZUP), demonstrated a reduction in risk of death in men with mHSPC.“Data from the eight-year follow-up of XTANDI are highly encouraging, as they show the progression-free survival and overall survival benefits are sustained out to at least eight years,” said Christopher Sweeney, MBBS, DHS, FRACP, ANZUP Cancer Trials Group Limited, Sydney, Australia, and ENZAMET follow-up primary investigator. “These results further support the value of XTANDI as a treatment regimen for metastatic hormone-sensitive prostate cancer.”With a median follow-up of 98 months, patients with mHSPC were treated with XTANDI plus testosterone suppression or NSAA plus testosterone suppression, each group with or without docetaxel. The median OS in the XTANDI group was 8.0 years and 5.8 years in the NSAA group (HR: 0.73; 95% CI, 0.63-0.86). OS at 96 months was 50% with XTANDI and 40% for NSAA; progression-free survival (PFS) also favored XTANDI over NSAA (HR: 0.49; 95% CI, 0.42-0.57). Prostate cancer accounted for 468 of all 622 deaths and were less frequent among those assigned XTANDI than NSAA (207 versus 261). Other causes accounted for a total of 154 deaths and were similarly frequent among those assigned XTANDI versus NSAA (78 versus 76). Mean duration of treatment was longer for XTANDI (58 months) than NSAA (36 months), with 33% remaining on XTANDI and 88% of these patients remained at the full dose of 160 mg.XTANDI is currently approved in more than 90 countries, including in the United States, European Union and Japan. Since its initial approval in 2012, over one million patients have been treated with XTANDI globally.1 About Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)Metastatic hormone-sensitive prostate cancer, also known as metastatic castration-sensitive prostate cancer, refers to prostate cancer that still responds to hormonal therapy and has spread outside of the prostate gland to other parts of the body, such as the lymph nodes, bones, lungs and liver.2About the ARCHES StudyThe Phase 3, randomized, double-blind, placebo-controlled, multi-national trial enrolled 1,150 patients with metastatic hormone-sensitive prostate cancer (mHSPC) at sites in the United States, Canada, Europe, South America and the Asia-Pacific region. Patients in the ARCHES trial were randomized to receive XTANDI 160 mg daily or placebo and continued on a luteinizing hormone-releasing hormone (LHRH) agonist or antagonist or had a history of bilateral orchiectomy. The ARCHES trial included patients with both low- and high-volume disease and both newly diagnosed patients with mHSPC and patients who had prior definitive therapy and subsequently developed metastatic disease. The trial also included some patients who had received recent treatment with docetaxel for mHSPC, but whose disease had not progressed. The primary endpoint of the trial was radiographic progression-free survival (rPFS), defined as the time from randomization to the first objective evidence of radiographic disease progression as assessed by central review, or death within 24 weeks of treatment discontinuation.In addition to the key secondary endpoint of overall survival at final analysis, a post hoc 5-year analysis was executed with the intent to further quantify long-term overall survival at a clinically meaningful landmark follow-up of five years.For more information on the global ARCHES trial, go to www.clinicaltrials.gov.About ENZAMETENZAMET is a trial led by ANZUP Cancer Trials Group Limited in collaboration with the NHMRC (National Health and Medical Research Council) Clinical Trials Centre at the University of Sydney with trial sites in Australia, Canada, Ireland, New Zealand, UK and United States. The trial evaluates the potential of enzalutamide plus androgen deprivation therapy (ADT) versus a conventional non-steroidal anti androgen (NSAA) plus ADT in 1,125 men with mHSPC. The primary endpoint for the trial is overall survival (OS). Additional details about ENZAMET (NCT02446405) are available on www.clinicaltrials.gov. Astellas provided funding and support for the ENZAMET trial.About XTANDI™ (enzalutamide)XTANDI (enzalutamide) is an androgen receptor signaling inhibitor. XTANDI is a standard of care and has received regulatory approvals in one or more countries around the world for use in men with metastatic hormone-sensitive prostate cancer (mHSPC), metastatic castration-resistant prostate cancer (mCRPC), non-metastatic castration-resistant prostate cancer (nmCRPC) and non-metastatic hormone-sensitive prostate cancer (nmHSPC) with high-risk biochemical recurrence (BCR). XTANDI is currently approved for one or more of these indications in more than 90 countries, including in the United States, European Union and Japan. Over one million patients have been treated with XTANDI globally.1About XTANDI (enzalutamide) and Important Safety InformationXTANDI (enzalutamide) is indicated for the treatment of patients with:• castration-resistant prostate cancer (CRPC)• metastatic castration-sensitive prostate cancer (mCSPC)• nonmetastatic castration sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR)Important Safety InformationWarnings and PrecautionsSeizure occurred in 0.6% of patients receiving XTANDI in eight randomized clinical trials. In a study of patients with predisposing factors for seizure, 2.2% of XTANDI-treated patients experienced a seizure. It is unknown whether anti-epileptic medications will prevent seizures with XTANDI. Patients in the study had one or more of the following predisposing factors: use of medications that may lower the seizure threshold, history of traumatic brain or head injury, history of cerebrovascular accident or transient ischemic attack, and Alzheimer’s disease, meningioma, or leptomeningeal disease from prostate cancer, unexplained loss of consciousness within the last 12 months, history of seizure, presence of a space occupying lesion of the brain, history of arteriovenous malformation, or history of brain infection. Advise patients of the risk of developing a seizure while taking XTANDI and of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others. Permanently discontinue XTANDI in patients who develop a seizure during treatment.Posterior Reversible Encephalopathy Syndrome (PRES) There have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder that can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XTANDI in patients who develop PRES.Hypersensitivity reactions, including edema of the face (0.5%), tongue (0.1%), or lip (0.1%) have been observed with XTANDI in eight randomized clinical trials. Pharyngeal edema has been reported in post-marketing cases. Advise patients who experience any symptoms of hypersensitivity to temporarily discontinue XTANDI and promptly seek medical care. Permanently discontinue XTANDI for serious hypersensitivity reactions.Ischemic Heart Disease In the combined data of five randomized, placebo-controlled clinical studies, ischemic heart disease occurred more commonly in patients on the XTANDI arm compared to patients on the placebo arm (3.5% vs 2%). Grade 3-4 ischemic events occurred in 1.8% of patients on XTANDI versus 1.1% on placebo. Ischemic events led to death in 0.4% of patients on XTANDI compared to 0.1% on placebo. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue XTANDI for Grade 3-4 ischemic heart disease.Falls and Fractures occurred in patients receiving XTANDI. Evaluate patients for fracture and fall risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone-targeted agents. In the combined data of five randomized, placebo-controlled clinical studies, falls occurred in 12% of patients treated with XTANDI compared to 6% of patients treated with placebo. Fractures occurred in 13% of patients treated with XTANDI and in 6% of patients treated with placebo.Embryo-Fetal Toxicity The safety and efficacy of XTANDI have not been established in females. XTANDI can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment with XTANDI and for 3 months after the last dose of XTANDI.Dysphagia or Choking Severe dysphagia or choking, including events that could be life-threatening requiring medical intervention or fatal, can occur due to XTANDI product size. Advise patients to take each capsule or tablet whole with a sufficient amount of water to ensure that all medication is successfully swallowed. Consider use of a smaller tablet size of XTANDI in patients who have difficulty swallowing. Discontinue XTANDI for patients who cannot swallow capsules or tablets.Adverse Reactions (ARs)In the data from the five randomized placebo-controlled trials, the most common ARs (≥ 10%) that occurred more frequently (≥ 2% over placebo) in XTANDI-treated patients were musculoskeletal pain, fatigue, hot flush, constipation, decreased appetite, diarrhea, hypertension, hemorrhage, fall, fracture, and headache. In the bicalutamide-controlled study, the most common ARs (≥ 10%) reported in XTANDI-treated patients were asthenia/fatigue, back pain, musculoskeletal pain, hot flush, hypertension, nausea, constipation, diarrhea, upper respiratory tract infection, and weight loss.In ARCHES, the placebo-controlled study of metastatic CSPC (mCSPC) patients, Grade 3 or higher ARs were reported in 24% of XTANDI-treated patients. Permanent discontinuation due to ARs as the primary reason was reported in 5% of XTANDI patients and 4% of placebo patients.Lab Abnormalities: Lab abnormalities that occurred in ≥ 5% of patients, and more frequently (> 2%) in the XTANDI arm compared to placebo in the pooled, randomized, placebo-controlled studies are hemoglobin decrease, neutrophil count decreased, white blood cell decreased, hyperglycemia, hypermagnesemia, hyponatremia, hypophosphatemia, and hypercalcemia.Hypertension: In the combined data from five randomized placebo-controlled clinical trials, hypertension was reported in 14.2% of XTANDI patients and 7.4% of placebo patients. Hypertension led to study discontinuation in < 1% of patients in each arm.Drug InteractionsEffect of Other Drugs on XTANDI Avoid coadministration with strong CYP2C8 inhibitors. If coadministration cannot be avoided, reduce the dosage of XTANDI.Avoid coadministration with strong CYP3A4 inducers. If coadministration cannot be avoided, increase the dosage of XTANDI.Effect of XTANDI on Other Drugs Avoid coadministration with certain CYP3A4, CYP2C9, and CYP2C19 substrates for which minimal decrease in concentration may lead to therapeutic failure of the substrate. If coadministration cannot be avoided, increase the dosage of these substrates in accordance with their Prescribing Information. In cases where active metabolites are formed, there may be increased exposure to the active metabolites.About AstellasAstellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into VALUE for patients. For more information, please visit our website at https://www.astellas.com/en.About Pfizer OncologyAt Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and bispecific antibodies, including other immune-oncology biologics. We are focused on delivering transformative therapies in some of the world’s most common cancers, including breast cancer, genitourinary cancer, hematology-oncology, and thoracic cancers, which includes lung cancer. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives.About the Pfizer/Astellas CollaborationIn October 2009, Medivation, Inc., which is now part of Pfizer (NYSE: PFE), and Astellas (TSE: 4503) entered into a global agreement to jointly develop and commercialize XTANDI (enzalutamide). The companies jointly commercialize XTANDI in the United States, and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing XTANDI outside the United States.Astellas Forward-Looking StatementIn this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties.Information about pharmaceutical products (including products currently in development), which is included in this press release is not intended to constitute an advertisement or medical advice.Pfizer Disclosure NoticeThe information contained in this release is as of May 22, 2025. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.This release contains forward-looking information about XTANDI (enzalutamide) and a new indication in the U.S. for the treatment of patients with nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis (high-risk BCR), including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of XTANDI; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; whether the EMBARK trial will meet the secondary endpoint of overall survival; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; whether and when drug applications for XTANDI may be filed in other jurisdictions; whether and when regulatory authorities in any jurisdictions may approve any such applications that may be pending or filed for XTANDI (including the application pending with the European Medicines Agency), which will depend on a myriad of factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether XTANDI for any potential indication will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety, and/or other matters that could affect the availability or commercial potential of XTANDI, including for the new indication; dependence on the efforts and funding by Astellas Pharma Inc. for the development, manufacturing and commercialization of XTANDI; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.Astellas Cautionary NotesIn this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties.Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.1 Astellas. Data on File. XTANDI patient. January 2023.2 Sartor, O., de Bono, J., Chi, K. N., Fizazi, K., Herrmann, K., Piulats, J. M., ... & Hussain, M. (2021). Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer. New England Journal of Medicine, 385(12), 1091-1103. Click below for a copy of the full press release 

Astellas Presents New Data that Explores Potential of its C… 2025年05月20日 09時00分

16 abstracts, including two oral presentations, feature new clinical data from Astellas’ oncology portfolioTOKYO, May 19, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) will present 16 abstracts featuring new data across its approved cancer therapies at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (May 30 - June 3). The research underscores Astellas’ dedication as a pioneer in oncology and focus on clinical outcomes that matter to patients.The abstracts include new post hoc analyses of long-term overall survival (OS) data for XTANDI (enzalutamide) and two analyses for PADCEV (enfortumab vedotin), which demonstrate how these standard-of-care medicines can continue to treat patients in metastatic, non-metastatic, castration-resistant, or hormone-sensitive prostate cancer patients and unresectable, locally advanced or metastatic urothelial cancer patients, respectively.Moitreyee Chatterjee-Kishore, Ph.D., M.B.A., Head of Oncology Development, Astellas“At Astellas, we are dedicated to transforming cancer care through innovative treatment approaches. The data we will present at ASCO this year, including new long-term follow-up data for advanced prostate and bladder cancers, reflect the pioneering role we continue to play in delivering outcomes that matter to patients. We continue to push the boundaries of cancer treatment with our growing pipeline, using novel modalities and precision medicine approaches, to benefit all eligible patients now and in the future.” Highlights from Astellas at the 2025 ASCO Annual Meeting will include a strong focus on Overall Survival (OS) data updates, confirming the value that these therapies bring to patients:Enzalutamide:The ARCHES five-year follow-up OS analysis of enzalutamide plus androgen-deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) will be featured in an oral presentationIn addition to the ARCHES five-year follow-up presentation, Astellas is supporting investigator-sponsored studies. Eight-year data assessing outcomes of enzalutamide vs non-steroidal anti-androgen (NSAA) in mHSPC will be presented from an independent, investigator-sponsored trial (ENZAMET) led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP).Enfortumab vedotinUrothelial carcinomaTwo analyses of the phase 3 EV-302 study of enfortumab vedotin in combination with pembrolizumab vs chemotherapy in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC)Exploratory analysis of responders will be presented in an oral presentationPoster presentation featuring long-term subgroup analysisBladder cancerA systematic review and meta-analysis of surrogate endpoints in muscle-invasive bladder cancer trials will be featured in a poster presentation.Shontelle Dodson, Executive Vice President, Head of Medical Affairs, Astellas “Long-term overall survival is the gold standard endpoint in cancer research. New post hoc analysis data from the ARCHES enzalutamide trial demonstrates our mission to help patients live longer, healthier lives. We are committed to maximizing the impact of our therapies as we continue to pioneer the oncology medicines of tomorrow.”Astellas Presentations at 2025 ASCO Annual MeetingEnzalutamide Presentation TitleLead AuthorPresentation DetailsARCHES 5-year follow-up overall survival analysis of enzalutamide plus androgen deprivation therapy in patients with metastatic hormone-sensitive prostate cancerA. ArmstrongType: Oral PresentationAbstract Number: 5005Date: June 3, 2025, 9:45am – 12:45pm CDT Cardiovascular event risk in patients with metastatic castration-resistant prostate cancer treated with enzalutamide or abiraterone acetate in the United States A. BryceType: Poster PresentationAbstract Number: 5041Date: June 2, 2025, 9:00am – 12:00pm CDTSecondary outcomes by prior definitive treatment in patients with high-risk biochemically recurrent prostate cancer treated with enzalutamide monotherapy: EMBARK post hoc analysisS. FreedlandType: Poster PresentationAbstract Number: 5103Date: June 2, 2025, 9:00am – 12:00pm CDTHow low do you need to go? Association between various prostate-specific antigen response measures and clinical outcomes in metastatic castration‑sensitive prostate cancer in the Veteran Health Administration dataS. FreedlandType: Poster PresentationAbstract Number: 5092Date: June 2, 2025, 9:00am – 12:00pm CDTAbiraterone acetate is associated with shorter overall survival than enzalutamide in patients with chemotherapy naïve metastatic castration-resistant prostate cancer: Real world data from the Flatiron electronic health records databaseD. GeorgeType: E-Publication OnlyAbstract Number for Publication: e17033Secondary outcomes by prior definitive treatment in patients with high-risk biochemically recurrent prostate cancer (treated with enzalutamide plus leuprolide (combo): EMBARK post hoc analysisN. ShoreType: E-Publication OnlyAbstract Number for Publication: e17127Corticosteroid Use and Risk of Adverse Events in Patients Treated for Metastatic Hormone-Sensitive Prostate CancerU. SwamiType: E-Publication OnlyAbstract Number for Publication: e17097Enfortumab vedotinPresentation TitleLead AuthorPresentation DetailsEV-302: Long-term subgroup analysis from the phase 3 global study of enfortumab vedotin in combination with pembrolizumab vs chemotherapy in previously untreated locally advanced or metastatic urothelial carcinomaJ. BedkeType: Poster PresentationAbstract Number: 4571Date: June 2, 2025, 9:00am – 12:00pm CDTExploratory analysis of responders from the phase 3 EV-302 trial of enfortumab vedotin plus pembrolizumab vs chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma S. GuptaType: Oral PresentationAbstract Number: 4502Date: June 1, 2025, 9:45am – 12:45pm CDTEvaluation of surrogate endpoints in muscle-invasive bladder cancer: A systematic review and meta-analysisM. GalskyType: Poster PresentationAbstract Number: 4580Date: June 2, 2025, 9:00am – 12:00pm CDTStudy EV-103 Cohort H: Neoadjuvant treatment with enfortumab vedotin monotherapy in cisplatin-ineligible patients with muscle-invasive bladder cancer: 3-year efficacy resultsN. MarType: Poster PresentationAbstract Number: 4583Date: June 2, 2025, 9:00am – 12:00pm CDTRecent trends in US real-world first-line treatment patterns for patients with locally advanced or metastatic urothelial carcinoma G. SonpavdeType: E-Publication OnlyAbstract Number for Publication: e16556Patient and clinician expert perspectives on the impactful symptoms of head and neck squamous cell carcinoma and its treatmentE. TheodorouType: E-Publication OnlyAbstract Number for Publication: e18001ZolbetuximabPresentation TitleLead AuthorPresentation DetailsA real-world study on epidemiology, biomarker test results, clinical characteristics, and treatment patterns of unresectable locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma in ChinaY. ChenType: E-Publication OnlyAbstract Number for Publication: e16013GilteritinibPresentation TitleLead AuthorPresentation DetailsReal-world adherence and tolerability of FLT3 inhibitors s post-allogeneic transplant maintenance therapy in older adults with AML: A Medicare claims cohort studyV. KennedyType: E-Publication OnlyPipelinePresentation TitleLead AuthorPresentation DetailsTrial in progress: Phase 1 study of the selective protein degrader ASP4396 in patients with locally advanced or metastatic solid tumors with KRAS G12D mutationShiraj SenType: Poster PresentationAbstract Number: TPS3178Date: June 2, 2025, 1:30 – 4:30pm CDT About AstellasAstellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com.About PADCEV and the Astellas, Pfizer and Merck CollaborationAstellas and Pfizer have a clinical collaboration agreement with Merck to evaluate the combination of Astellas' and Pfizer's PADCEV (enfortumab vedotin) and Merck's KEYTRUDA (pembrolizumab) in patients with previously untreated metastatic urothelial cancer. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the United States and Canada).About XTANDI and the Pfizer/Astellas CollaborationIn October 2009, Medivation, Inc., which is now part of Pfizer (NYSE:PFE), and Astellas (TSE: 4503) entered into a commercial agreement to jointly develop and commercialize XTANDI® (enzalutamide) in the United States, while Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing the product outside the United States. Pfizer receives alliance revenues as a share of U.S. profits and receives royalties on sales outside the U.S.XTANDI Important Safety InformationWarnings and PrecautionsSeizure occurred in 0.6% of patients receiving XTANDI in eight randomized clinical trials. In a study of patients with predisposing factors for seizure, 2.2% of XTANDI-treated patients experienced a seizure. It is unknown whether anti-epileptic medications will prevent seizures with XTANDI. Patients in the study had one or more of the following predisposing factors: use of medications that may lower the seizure threshold, history of traumatic brain or head injury, history of cerebrovascular accident or transient ischemic attack, and Alzheimer’s disease, meningioma, or leptomeningeal disease from prostate cancer, unexplained loss of consciousness within the last 12 months, history of seizure, presence of a space occupying lesion of the brain, history of arteriovenous malformation, or history of brain infection. Advise patients of the risk of developing a seizure while taking XTANDI and of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others. Permanently discontinue XTANDI in patients who develop a seizure during treatment.Posterior Reversible Encephalopathy Syndrome (PRES) There have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder that can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XTANDI in patients who develop PRES.Hypersensitivity reactions, including edema of the face (0.5%), tongue (0.1%), or lip (0.1%) have been observed with XTANDI in eight randomized clinical trials. Pharyngeal edema has been reported in post-marketing cases. Advise patients who experience any symptoms of hypersensitivity to temporarily discontinue XTANDI and promptly seek medical care. Permanently discontinue XTANDI for serious hypersensitivity reactions.Ischemic Heart Disease In the combined data of five randomized, placebo-controlled clinical studies, ischemic heart disease occurred more commonly in patients on the XTANDI arm compared to patients on the placebo arm (3.5% vs 2%). Grade 3-4 ischemic events occurred in 1.8% of patients on XTANDI versus 1.1% on placebo. Ischemic events led to death in 0.4% of patients on XTANDI compared to 0.1% on placebo. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue XTANDI for Grade 3-4 ischemic heart disease.Falls and Fractures occurred in patients receiving XTANDI. Evaluate patients for fracture and fall risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone-targeted agents. In the combined data of five randomized, placebo-controlled clinical studies, falls occurred in 12% of patients treated with XTANDI compared to 6% of patients treated with placebo. Fractures occurred in 13% of patients treated with XTANDI and in 6% of patients treated with placebo.Embryo-Fetal Toxicity The safety and efficacy of XTANDI have not been established in females.XTANDI can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment with XTANDI and for 3 months after the last dose of XTANDI.Dysphagia or Choking Severe dysphagia or choking, including events that could be life-threatening requiring medical intervention or fatal, can occur due to XTANDI product size. Advise patients to take each capsule or tablet whole with a sufficient amount of water to ensure that all medication is successfully swallowed. Consider use of a smaller tablet size of XTANDI in patients who have difficulty swallowing. Discontinue XTANDI for patients who cannot swallow capsules or tablets.Adverse Reactions (ARs)In the data from the five randomized placebo-controlled trials, the most common ARs (≥ 10%) that occurred more frequently (≥ 2% over placebo) in XTANDI-treated patients were musculoskeletal pain, fatigue, hot flush, constipation, decreased appetite, diarrhea, hypertension, hemorrhage, fall, fracture, and headache. In the bicalutamide-controlled study, the most common ARs (≥ 10%) reported in XTANDI-treated patients were asthenia/fatigue, back pain, musculoskeletal pain, hot flush, hypertension, nausea, constipation, diarrhea, upper respiratory tract infection, and weight loss.In AFFIRM, the placebo-controlled study of metastatic CRPC (mCRPC) patients who previously received docetaxel, Grade 3 and higher ARs were reported among 47% of XTANDI-treated patients.Discontinuations due to ARs were reported for 16% of XTANDI-treated patients. In PREVAIL, the placebo-controlled study of chemotherapy-naive mCRPC patients, Grade 3-4 ARs were reported in 44% of XTANDI patients and 37% of placebo patients. Discontinuations due to ARs were reported for 6% of XTANDI-treated patients. In TERRAIN, the bicalutamide-controlled study of chemotherapy-naive mCRPC patients, Grade 3-4 ARs were reported in 39% of XTANDI patients and 38% of bicalutamide patients. Discontinuations with an AR as the primary reason were reported for 8% of XTANDI patients and 6% of bicalutamide patients.In PROSPER, the placebo-controlled study of nonmetastatic CRPC (nmCRPC) patients, Grade 3 or higher ARs were reported in 31% of XTANDI patients and 23% of placebo patients.Discontinuations with an AR as the primary reason were reported for 9% of XTANDI patients and 6% of placebo patients.In ARCHES, the placebo-controlled study of metastatic CSPC (mCSPC) patients, Grade 3 or higher ARs were reported in 24% of XTANDI-treated patients. Permanent discontinuation due to ARs as the primary reason was reported in 5% of XTANDI patients and 4% of placebo patients.In EMBARK, the placebo-controlled study of nonmetastatic CSPC (nmCSPC) with high-risk biochemical recurrence (BCR) patients, Grade 3 or higher adverse reactions during the total duration of treatment were reported in 46% of patients treated with XTANDI plus leuprolide, 50% of patients receiving XTANDI as a single agent, and 43% of patients receiving placebo plus leuprolide. Permanent treatment discontinuation due to adverse reactions during the total duration of treatment as the primary reason was reported in 21% of patients treated with XTANDI plus leuprolide, 18% of patients receiving XTANDI as a single agent, and 10% of patients receiving placebo plus leuprolide.Lab Abnormalities: Lab abnormalities that occurred in ≥ 5% of patients, and more frequently (> 2%) in the XTANDI arm compared to placebo in the pooled, randomized, placebo-controlled studies are hemoglobin decrease, neutrophil count decreased, white blood cell decreased, hyperglycemia, hypermagnesemia, hyponatremia, hypophosphatemia, and hypercalcemia.Hypertension: In the combined data from five randomized placebo-controlled clinical trials, hypertension was reported in 14% of XTANDI patients and 7% of placebo patients. Hypertension led to study discontinuation in < 1% of patients in each arm.Drug InteractionsEffect of Other Drugs on XTANDI Avoid coadministration with strong CYP2C8 inhibitors. If coadministration cannot be avoided, reduce the dosage of XTANDI.Avoid coadministration with strong CYP3A4 inducers. If coadministration cannot be avoided, increase the dosage of XTANDI.Effect of XTANDI on Other Drugs Avoid coadministration with certain CYP3A4, CYP2C9, and CYP2C19 substrates for which minimal decrease in concentration may lead to therapeutic failure of the substrate. If coadministration cannot be avoided, increase the dosage of these substrates in accordance with their Prescribing Information. In cases where active metabolites are formed, there may be increased exposure to the active metabolites.Full Prescribing InformationPADCEV Important Safety InformationWarnings and PrecautionsSkin reactions Severe cutaneous adverse reactions, including fatal cases of SJS or TEN occurred in patients treated with PADCEV. SJS and TEN occurred predominantly during the first cycle of treatment but may occur later. Skin reactions occurred in 70% (all grades) of the 564 patients treated with PADCEV in combination with pembrolizumab in clinical trials. When PADCEV was given in combination with pembrolizumab, the incidence of skin reactions, including severe events, occurred at a higher rate compared to PADCEV as a single agent. The majority of the skin reactions that occurred with combination therapy included maculo-papular rash, macular rash and papular rash. Grade 3-4 skin reactions occurred in 17% of patients (Grade 3: 16%, Grade 4: 1%), including maculo-papular rash, bullous dermatitis, dermatitis, exfoliative dermatitis, pemphigoid, rash, erythematous rash, macular rash, and papular rash. A fatal reaction of bullous dermatitis occurred in one patient (0.2%). The median time to onset of severe skin reactions was 1.7 months (range: 0.1 to 17.2 months). Skin reactions led to discontinuation of PADCEV in 6% of patients.Skin reactions occurred in 58% (all grades) of the 720 patients treated with PADCEV as a single agent in clinical trials. Twenty-three percent (23%) of patients had maculo-papular rash and 34% had pruritus. Grade 3-4 skin reactions occurred in 14% of patients, including maculo-papular rash, erythematous rash, rash or drug eruption, symmetrical drug-related intertriginous and flexural exanthema (SDRIFE), bullous dermatitis, exfoliative dermatitis, and palmar-plantar erythrodysesthesia. The median time to onset of severe skin reactions was 0.6 months (range: 0.1 to 8 months). Among patients experiencing a skin reaction leading to dose interruption who then restarted PADCEV (n=75), 24% of patients restarting at the same dose and 24% of patients restarting at a reduced dose experienced recurrent severe skin reactions. Skin reactions led to discontinuation of PADCEV in 3.1% of patients.Monitor patients closely throughout treatment for skin reactions. Consider topical corticosteroids and antihistamines, as clinically indicated. For persistent or recurrent Grade 2 skin reactions, consider withholding PADCEV until Grade ≤1. Withhold PADCEV and refer for specialized care for suspected SJS, TEN or for Grade 3 skin reactions. Permanently discontinue PADCEV in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions.Hyperglycemia and diabetic ketoacidosis (DKA), including fatal events, occurred in patients with and without pre-existing diabetes mellitus, treated with PADCEV. Patients with baseline hemoglobin A1C ≥8% were excluded from clinical trials. In clinical trials of PADCEV as a single agent, 17% of the 720 patients treated with PADCEV developed hyperglycemia of any grade; 7% of patients developed Grade 3-4 hyperglycemia (Grade 3: 6.5%, Grade 4: 0.6%). Fatal events of hyperglycemia and DKA occurred in one patient each (0.1%). The incidence of Grade 3-4 hyperglycemia increased consistently in patients with higher body mass index and in patients with higher baseline A1C. The median time to onset of hyperglycemia was 0.5 months (range: 0 to 20 months). Hyperglycemia led to discontinuation of PADCEV in 0.7% of patients. Five percent (5%) of patients required initiation of insulin therapy for treatment of hyperglycemia. Of the patients who initiated insulin therapy for treatment of hyperglycemia, 66% (23/35) discontinued insulin at the time of last evaluation. Closely monitor blood glucose levels in patients with, or at risk for, diabetes mellitus or hyperglycemia. If blood glucose is elevated (>250 mg/dL), withhold PADCEV.Pneumonitis/Interstitial Lung Disease (ILD) Severe, life-threatening or fatal pneumonitis/ILD occurred in patients treated with PADCEV. When PADCEV was given in combination with pembrolizumab, 10% of the 564 patients treated with combination therapy had pneumonitis/ILD of any grade and 4% had Grade 3-4. A fatal event of pneumonitis/ILD occurred in two patients (0.4%). The incidence of pneumonitis/ILD, including severe events, occurred at a higher rate when PADCEV was given in combination with pembrolizumab compared to PADCEV as a single agent. The median time to onset of any grade pneumonitis/ILD was 4 months (range: 0.3 to 26 months).In clinical trials of PADCEV as a single agent, 3% of the 720 patients treated with PADCEV had pneumonitis/ILD of any grade and 0.8% had Grade 3-4. The median time to onset of any grade pneumonitis/ILD was 2.9 months (range: 0.6 to 6 months).Monitor patients for signs and symptoms indicative of pneumonitis/ILD such as hypoxia, cough, dyspnea or interstitial infiltrates on radiologic exams. Evaluate and exclude infectious, neoplastic and other causes for such signs and symptoms through appropriate investigations. Withhold PADCEV for patients who develop Grade 2 pneumonitis/ILD and consider dose reduction. Permanently discontinue PADCEV in all patients with Grade 3 or 4 pneumonitis/ILD.Peripheral neuropathy (PN) When PADCEV was given in combination with pembrolizumab, 67% of the 564 patients treated with combination therapy had PN of any grade, 36% had Grade 2 neuropathy, and 7% had Grade 3 neuropathy. The incidence of PN occurred at a higher rate when PADCEV was given in combination with pembrolizumab compared to PADCEV as a single agent. The median time to onset of Grade ≥2 PN was 6 months (range: 0.3 to 25 months).PN occurred in 53% of the 720 patients treated with PADCEV as a single agent in clinical trials including 38% with sensory neuropathy, 8% with muscular weakness and 7% with motor neuropathy. Thirty percent of patients experienced Grade 2 reactions and 5% experienced Grade 3-4 reactions. PN occurred in patients treated with PADCEV with or without preexisting PN. The median time to onset of Grade ≥2 PN was 4.9 months (range: 0.1 to 20 months). Neuropathy led to treatment discontinuation in 6% of patients.Monitor patients for symptoms of new or worsening PN and consider dose interruption or dose reduction of PADCEV when PN occurs. Permanently discontinue PADCEV in patients who develop Grade ≥3 PN.Ocular disorders were reported in 40% of the 384 patients treated with PADCEV as a single agent in clinical trials in which ophthalmologic exams were scheduled. The majority of these events involved the cornea and included events associated with dry eye such as keratitis, blurred vision, increased lacrimation, conjunctivitis, limbal stem cell deficiency, and keratopathy. Dry eye symptoms occurred in 30% of patients, and blurred vision occurred in 10% of patients, during treatment with PADCEV. The median time to onset to symptomatic ocular disorder was 1.7 months (range: 0 to 30.6 months). Monitor patients for ocular disorders. Consider artificial tears for prophylaxis of dry eyes and ophthalmologic evaluation if ocular symptoms occur or do not resolve. Consider treatment with ophthalmic topical steroids, if indicated after an ophthalmic exam. Consider dose interruption or dose reduction of PADCEV for symptomatic ocular disorders.Infusion site extravasation Skin and soft tissue reactions secondary to extravasation have been observed after administration of PADCEV. Of the 720 patients treated with PADCEV as a single agent in clinical trials, 1% of patients experienced skin and soft tissue reactions, including 0.3% who experienced Grade 3-4 reactions. Reactions may be delayed. Erythema, swelling, increased temperature, and pain worsened until 2-7 days after extravasation and resolved within 1-4 weeks of peak. Two patients (0.3%) developed extravasation reactions with secondary cellulitis, bullae, or exfoliation. Ensure adequate venous access prior to starting PADCEV and monitor for possible extravasation during administration. If extravasation occurs, stop the infusion and monitor for adverse reactions.Embryo-fetal toxicity PADCEV can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to the fetus. Advise female patients of reproductive potential to use effective contraception during PADCEV treatment and for 2 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with PADCEV and for 4 months after the last dose.ADVERSE REACTIONSMost common adverse reactions, including laboratory abnormalities (≥20%) (PADCEV in combination with pembrolizumab)Increased aspartate aminotransferase (AST), increased creatinine, rash, increased glucose, PN, increased lipase, decreased lymphocytes, increased alanine aminotransferase (ALT), decreased hemoglobin, fatigue, decreased sodium, decreased phosphate, decreased albumin, pruritus, diarrhea, alopecia, decreased weight, decreased appetite, increased urate, decreased neutrophils, decreased potassium, dry eye, nausea, constipation, increased potassium, dysgeusia, urinary tract infection and decreased platelets.Most common adverse reactions, including laboratory abnormalities (≥20%) (PADCEV monotherapy)Increased glucose, increased AST, decreased lymphocytes, increased creatinine, rash, fatigue, PN, decreased albumin, decreased hemoglobin, alopecia, decreased appetite, decreased neutrophils, decreased sodium, increased ALT, decreased phosphate, diarrhea, nausea, pruritus, increased urate, dry eye, dysgeusia, constipation, increased lipase, decreased weight, decreased platelets, abdominal pain, dry skin.EV-302 Study: 440 patients with previously untreated la/mUC (PADCEV in combination with pembrolizumab)Serious adverse reactions occurred in 50% of patients treated with PADCEV in combination with pembrolizumab. The most common serious adverse reactions (≥2%) were rash (6%), acute kidney injury (5%), pneumonitis/ILD (4.5%), urinary tract infection (3.6%), diarrhea (3.2%), pneumonia (2.3%), pyrexia (2%), and hyperglycemia (2%). Fatal adverse reactions occurred in 3.9% of patients treated with PADCEV in combination with pembrolizumab including acute respiratory failure (0.7%), pneumonia (0.5%), and pneumonitis/ILD (0.2%).Adverse reactions leading to discontinuation of PADCEV occurred in 35% of patients. The most common adverse reactions (≥2%) leading to discontinuation of PADCEV were PN (15%), rash (4.1%) and pneumonitis/ILD (2.3%). Adverse reactions leading to dose interruption of PADCEV occurred in 73% of patients. The most common adverse reactions (≥2%) leading to dose interruption of PADCEV were PN (22%), rash (16%), COVID 19 (10%), diarrhea (5%), pneumonitis/ILD (4.8%), fatigue (3.9%), hyperglycemia (3.6%), increased ALT (3%) and pruritus (2.5%). Adverse reactions leading to dose reduction of PADCEV occurred in 42% of patients. The most common adverse reactions (≥2%) leading to dose reduction of PADCEV were rash (16%), PN (13%) and fatigue (2.7%).EV-103 Study: 121 patients with previously untreated la/mUC who were not eligible for cisplatin-containing chemotherapy (PADCEV in combination with pembrolizumab)Serious adverse reactions occurred in 50% of patients treated with PADCEV in combination with pembrolizumab; the most common (≥2%) were acute kidney injury (7%), urinary tract infection (7%), urosepsis (5%), sepsis (3.3%), pneumonia (3.3%), hematuria (3.3%), pneumonitis/ILD (3.3%), urinary retention (2.5%), diarrhea (2.5%), myasthenia gravis (2.5%), myositis (2.5%), anemia (2.5%), and hypotension (2.5%). Fatal adverse reactions occurred in 5% of patients treated with PADCEV in combination with pembrolizumab, including sepsis (1.6%), bullous dermatitis (0.8%), myasthenia gravis (0.8%), and pneumonitis/ILD (0.8%). Adverse reactions leading to discontinuation of PADCEV occurred in 36% of patients; the most common (≥2%) were PN (20%) and rash (6%). Adverse reactions leading to dose interruption of PADCEV occurred in 69% of patients; the most common (≥2%) were PN (18%), rash (12%), increased lipase (6%), pneumonitis/ILD (6%), diarrhea (4.1%), acute kidney injury (3.3%), increased ALT (3.3%), fatigue (3.3%), neutropenia (3.3%), urinary tract infection (3.3%), increased amylase (2.5%), anemia (2.5%), COVID 19 (2.5%), hyperglycemia (2.5%), and hypotension (2.5%). Adverse reactions leading to dose reduction of PADCEV occurred in 45% of patients; the most common (≥2%) were PN (17%), rash (12%), fatigue (5%), neutropenia (5%), and diarrhea (4.1%).EV-301 Study: 296 patients previously treated with a PD-1/L1 inhibitor and platinum-based chemotherapy (PADCEV monotherapy)Serious adverse reactions occurred in 47% of patients treated with PADCEV; the most common (≥2%) were urinary tract infection, acute kidney injury (7% each), and pneumonia (5%). Fatal adverse reactions occurred in 3% of patients, including multiorgan dysfunction (1%), hepatic dysfunction, septic shock, hyperglycemia, pneumonitis/ILD, and pelvic abscess (0.3% each). Adverse reactions leading to discontinuation occurred in 17% of patients; the most common (≥2%) were PN (5%) and rash (4%). Adverse reactions leading to dose interruption occurred in 61% of patients; the most common (≥4%) were PN (23%), rash (11%), and fatigue (9%). Adverse reactions leading to dose reduction occurred in 34% of patients; the most common (≥2%) were PN (10%), rash (8%), decreased appetite, and fatigue (3% each).EV-201, Cohort 2 Study: 89 patients previously treated with a PD-1/L1 inhibitor and not eligible for cisplatin-based chemotherapy (PADCEV monotherapy)Serious adverse reactions occurred in 39% of patients treated with PADCEV; the most common (≥3%) were pneumonia, sepsis, and diarrhea (5% each). Fatal adverse reactions occurred in 8% of patients, including acute kidney injury (2.2%), metabolic acidosis, sepsis, multiorgan dysfunction, pneumonia, and pneumonitis/ILD (1.1% each). Adverse reactions leading to discontinuation occurred in 20% of patients; the most common (≥2%) was PN (7%). Adverse reactions leading to dose interruption occurred in 60% of patients; the most common (≥3%) were PN (19%), rash (9%), fatigue (8%), diarrhea (5%), increased AST, and hyperglycemia (3% each). Adverse reactions leading to dose reduction occurred in 49% of patients; the most common (≥3%) were PN (19%), rash (11%), and fatigue (7%).DRUG INTERACTIONSEffects of other drugs on PADCEV (Dual P-gp and Strong CYP3A4 Inhibitors)Concomitant use with dual P-gp and strong CYP3A4 inhibitors may increase unconjugated monomethyl auristatin E exposure, which may increase the incidence or severity of PADCEV toxicities. Closely monitor patients for signs of toxicity when PADCEV is given concomitantly with dual P-gp and strong CYP3A4 inhibitors.SPECIFIC POPULATIONSLactation Advise lactating women not to breastfeed during treatment with PADCEV and for 3 weeks after the last dose.Hepatic impairment Avoid the use of PADCEV in patients with moderate or severe hepatic impairment.Full Prescribing InformationVYLOY Important Safety InformationWarnings and PrecautionsHypersensitivity reactions, including serious anaphylaxis reactions, and serious and fatal infusion-related reactions (IRR) have been reported in clinical studies when VYLOY has been administered. Any grade hypersensitivity reactions, including anaphylactic reactions, occurring with VYLOY in combination with mFOLFOX6 or CAPOX was 18%. Severe (Grade 3 or 4) hypersensitivity reactions, including anaphylactic reactions, occurred in 2% of patients. Seven patients (1.3%) permanently discontinued VYLOY for hypersensitivity reactions, including two patients (0.4%) who permanently discontinued VYLOY due to anaphylactic reactions. Seventeen (3.2%) patients required dose interruption, and three patients (0.6%) required infusion rate reduction due to hypersensitivity reactions. All grade IRRs occurred in 3.2% in patients administered VYLOY in combination with mFOLFOX6 or CAPOX. Severe (Grade 3) IRRs occurred in 2 (0.4%) patients who received VYLOY. An IRR led to permanent discontinuation of VYLOY in 2 (0.4%) patients and dose interruption in 7 (1.3%) patients. The infusion rate was reduced for VYLOY for 2 (0.4%) patients due to an IRR. Monitor patients during infusion with VYLOY and for 2 hours after completion of infusion or longer if clinically indicated, for hypersensitivity reactions with symptoms and signs that are highly suggestive of anaphylaxis (urticaria, repetitive cough, wheeze and throat tightness/change in voice). Monitor patients for signs and symptoms of IRRs including nausea, vomiting, abdominal pain, salivary hypersecretion, pyrexia, chest discomfort, chills, back pain, cough and hypertension. If a severe or life-threatening hypersensitivity or IRR reaction occurs, discontinue VYLOY permanently, treat symptoms according to standard medical care, and monitor until symptoms resolve. For any Grade 2 hypersensitivity or IRR, interrupt the VYLOY infusion until Grade ≤1, then resume at a reduced infusion rate for the remaining infusion. Follow Grade 2 management for Grade 3 infusion-related nausea and vomiting. Premedicate the patient with antihistamines for the subsequent infusions, and closely monitor the patient for symptoms and signs of a hypersensitivity reaction. The infusion rate may be gradually increased as tolerated.Severe Nausea and Vomiting. VYLOY is emetogenic. Nausea and vomiting occurred more often during the first cycle of treatment. All grade nausea and vomiting occurred in 82% and 67% respectively of patients treated with VYLOY in combination with mFOLFOX6 and 69% and 66% in combination with CAPOX, respectively. Severe (Grade 3) nausea occurred in 16% and 9% of patients treated with VYLOY in combination with mFOLFOX6 or CAPOX respectively. Severe (Grade 3) vomiting occurred in 16% and 12% of patients treated with VYLOY in combination with mFOLFOX6 or CAPOX. Nausea led to permanent discontinuation of VYLOY in combination with mFOLFOX6 or CAPOX in 18 (3.4%) patients and dose interruption in 147 (28%) patients. Vomiting led to permanent discontinuation of VYLOY in combination with mFOLFOX6 or CAPOX in 20 (3.8%) patients and dose interruption in 150 (28%) patients. Pretreat with antiemetics prior to each infusion of VYLOY. Manage patients during and after infusion with antiemetics or fluid replacement. Interrupt the infusion, or permanently discontinue VYLOY based on severity.ADVERSE REACTIONSMost common adverse reactions (≥15%): Nausea, vomiting, fatigue, decreased appetite, diarrhea, peripheral sensory neuropathy, abdominal pain, constipation, decreased weight, hypersensitivity reactions, and pyrexia.Most common laboratory abnormalities (≥15%): Decreased neutrophil count, decreased leucocyte count, decreased albumin, increased creatinine, decreased hemoglobin, increased glucose, decreased lymphocyte count, increased aspartate aminotransferase, decreased platelets, increased alkaline phosphatase, increased alanine aminotransferase, decreased glucose, decreased sodium, increased phosphate, decreased potassium, and decreased magnesium.SPOTLIGHT Study: 279 patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors were CLDN18.2 positive who received at least one dose of VYLOY in combination with mFOLFOX6Serious adverse reactions occurred in 45% of patients treated with VYLOY in combination with mFOLFOX6; the most common serious adverse reactions (≥2%) were vomiting (8%), nausea (7%), neutropenia (2.9%), febrile neutropenia (2.9%), diarrhea (2.9%), intestinal obstruction (3.2%), pyrexia (2.5%), pneumonia (2.5%), respiratory failure (2.2%), pulmonary embolism (2.2%), decreased appetite (2.1%) and sepsis (2.0%). Fatal adverse reactions occurred in 5% of patients who received VYLOY in combination with mFOLFOX6 including sepsis (1.4%), pneumonia (1.1%), respiratory failure (1.1%), intestinal obstruction (0.7%), acute hepatic failure (0.4%), acute myocardial infarction (0.4%), death (0.4%), disseminated intravascular coagulation (0.4%), encephalopathy (0.4%), and upper gastrointestinal hemorrhage (0.4%). Permanent discontinuation of VYLOY due to an adverse reaction occurred in 20% of patients; the most common adverse reactions leading to discontinuation (≥2%) were nausea and vomiting. Dosage interruptions of VYLOY due to an adverse reaction occurred in 75% of patients; the most common adverse reactions leading to dose interruption (≥5%) were nausea, vomiting, neutropenia, abdominal pain, fatigue, and hypertension.GLOW Study: 254 patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors were CLDN18.2 positive who received at least one dose of VYLOY in combination with CAPOXSerious adverse reactions occurred in 47% of patients treated with VYLOY in combination with CAPOX; the most common serious adverse reactions (≥2%) were vomiting (6%), nausea (4.3%), decreased appetite (3.9%), decreased platelet count (3.1%), upper gastrointestinal hemorrhage (2.8%), diarrhea (2.8%), pneumonia (2.4%), pulmonary embolism (2.3%), and pyrexia (2.0%). Fatal adverse reactions occurred in 8% of patients who received VYLOY in combination with CAPOX including sepsis (1.2%), pneumonia (0.4%), death (0.8%), upper gastrointestinal hemorrhage (0.8%), cerebral hemorrhage (0.8%), abdominal infection (0.4%), acute respiratory distress syndrome (0.4%), cardio-respiratory arrest (0.4%), decreased platelet count (0.4%), disseminated intravascular coagulation (0.4%), dyspnea (0.4%), gastric perforation (0.4%), hemorrhagic ascites (0.4%), procedural complication (0.4%), sudden death (0.4%), and syncope (0.4%). Permanent discontinuation of VYLOY due to an adverse reaction occurred in 19% of patients; the most common adverse reaction leading to discontinuation (≥2%) was vomiting. Dosage interruption of VYLOY due to an adverse reaction occurred in 55% of patients; the most common adverse reactions leading to dose interruption (≥2%) were nausea, vomiting, neutropenia, thrombocytopenia, anemia, fatigue, infusion-related reaction, and abdominal pain.SPECIFIC POPULATIONSLactation Advise lactating women not to breastfeed during treatment with VYLOY and for 8 months after the last dose.Full Prescribing InformationXOSPATA Important Safety InformationContraindicationsXOSPATA is contraindicated in patients with hypersensitivity to gilteritinib or any of the excipients. Anaphylactic reactions have been observed in clinical trials.Warnings and PrecautionsDifferentiation Syndrome (See BOXED WARNING) 3% of 319 patients treated with XOSPATA in the clinical trials experienced differentiation syndrome. Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal if not treated. Symptoms and other clinical findings of differentiation syndrome in patients treated with XOSPATA included fever, dyspnea, pleural effusion, pericardial effusion, pulmonary edema, hypotension, rapid weight gain, peripheral edema, rash, and renal dysfunction. Some cases had concomitant acute febrile neutrophilic dermatosis. Differentiation syndrome occurred as early as 1 day and up to 82 days after XOSPATA initiation and has been observed with or without concomitant leukocytosis. If differentiation syndrome is suspected, initiate dexamethasone 10 mg IV every 12 hours (or an equivalent dose of an alternative oral or IV corticosteroid) and hemodynamic monitoring until improvement. Taper corticosteroids after resolution of symptoms and administer corticosteroids for a minimum of 3 days. Symptoms of differentiation syndrome may recur with premature discontinuation of corticosteroid treatment. If severe signs and/or symptoms persist for more than 48 hours after initiation of corticosteroids, interrupt XOSPATA until signs and symptoms are no longer severe.Posterior Reversible Encephalopathy Syndrome (PRES) 1% of 319 patients treated with XOSPATA in the clinical trials experienced posterior reversible encephalopathy syndrome (PRES) with symptoms including seizure and altered mental status. Symptoms have resolved after discontinuation of XOSPATA. A diagnosis of PRES requires confirmation by brain imaging, preferably magnetic resonance imaging (MRI). Discontinue XOSPATA in patients who develop PRES.Prolonged QT Interval XOSPATA has been associated with prolonged cardiac ventricular repolarization (QT interval). 1% of the 317 patients with a post-baseline QTc measurement on treatment with XOSPATA in the clinical trial were found to have a QTc interval greater than 500 msec and 7% of patients had an increase from baseline QTc greater than 60 msec. Perform electrocardiogram (ECG) prior to initiation of treatment with XOSPATA, on days 8 and 15 of cycle 1, and prior to the start of the next two subsequent cycles. Interrupt and reduce XOSPATA dosage in patients who have a QTcF >500 msec. Hypokalemia or hypomagnesemia may increase the QT prolongation risk. Correct hypokalemia or hypomagnesemia prior to and during XOSPATA administration.Pancreatitis 4% of 319 patients treated with XOSPATA in the clinical trials experienced pancreatitis. Evaluate patients who develop signs and symptoms of pancreatitis. Interrupt and reduce the dose of XOSPATA in patients who develop pancreatitis.Embryo-Fetal Toxicity XOSPATA can cause embryo-fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with XOSPATA and for 6 months after the last dose of XOSPATA. Advise males with female partners of reproductive potential to use effective contraception during treatment with XOSPATA and for 4 months after the last dose of XOSPATA. Pregnant women, patients becoming pregnant while receiving XOSPATA or male patients with pregnant female partners should be apprised of the potential risk to the fetus.Adverse ReactionsFatal adverse reactions occurred in 2% of patients receiving XOSPATA. These were cardiac arrest (1%) and one case each of differentiation syndrome and pancreatitis. The most frequent (≥5%) nonhematological serious adverse reactions reported in patients were fever (13%), dyspnea (9%), renal impairment (8%), transaminase increased (6%) and noninfectious diarrhea (5%).7% discontinued XOSPATA treatment permanently due to an adverse reaction. The most common (>1%) adverse reactions leading to discontinuation were aspartate aminotransferase increased (2%) and alanine aminotransferase increased (2%).The most frequent (≥5%) grade ≥3 nonhematological adverse reactions reported in patients were transaminase increased (21%), dyspnea (12%), hypotension (7%), mucositis (7%), myalgia/arthralgia (7%), and fatigue/malaise (6%).Other clinically significant adverse reactions occurring in ≤10% of patients included: electrocardiogram QT prolonged (9%), hypersensitivity (8%), pancreatitis (5%), cardiac failure (4%), pericardial effusion (4%), acute febrile neutrophilic dermatosis (3%), differentiation syndrome (3%), pericarditis/myocarditis (2%), large intestine perforation (1%), and posterior reversible encephalopathy syndrome (1%).Lab Abnormalities Shifts to grades 3-4 nonhematologic laboratory abnormalities in XOSPATA treated patients included phosphate decreased (14%), alanine aminotransferase increased (13%), sodium decreased (12%), aspartate aminotransferase increased (10%), calcium decreased (6%), creatine kinase increased (6%), triglycerides increased (6%), creatinine increased (3%), and alkaline phosphatase increased (2%).Drug InteractionsCombined P-gp and Strong CYP3A Inducers Concomitant use of XOSPATA with a combined P-gp and strong CYP3A inducer decreases XOSPATA exposure which may decrease XOSPATA efficacy. Avoid concomitant use of XOSPATA with combined P-gp and strong CYP3A inducers.Strong CYP3A inhibitors Concomitant use of XOSPATA with a strong CYP3A inhibitor increases XOSPATA exposure. Consider alternative therapies that are not strong CYP3A inhibitors. If the concomitant use of these inhibitors is considered essential for the care of the patient, monitor patient more frequently for XOSPATA adverse reactions. Interrupt and reduce XOSPATA dosage in patients with serious or life-threatening toxicity.Drugs that Target 5HT2B Receptor or Sigma Nonspecific Receptor Concomitant use of XOSPATA may reduce the effects of drugs that target the 5HT2B receptor or the sigma nonspecific receptor (e.g., escitalopram, fluoxetine, sertraline). Avoid concomitant use of these drugs with XOSPATA unless their use is considered essential for the care of the patient.P-gp, BCRP, and OCT1 Substrates Based on in vitro data, gilteritinib is a P-gp, breast cancer resistant protein (BCRP), and organic cation transporter 1 (OCT1) inhibitor. Coadministration of gilteritinib may increase the exposure of P-gp, BCRP, and OCT1 substrates, which may increase the incidence and severity of adverse reactions of these substrates. For P-gp, BCRP, or OCT1 substrates where small concentration changes may lead to serious adverse reactions, decrease the dose or modify the dosing frequency of such substrate and monitor for adverse reactions as recommended in the respective prescribing information.Specific PopulationsLactation Advise women not to breastfeed during treatment with XOSPATA and for 2 months after the last dose.Full Prescribing InformationCautionary NotesIn this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. Click below for a copy of the full press release

Addressing Global Health Challenges 2025年05月19日 10時00分

Notice Regarding Continuation of the Performance-linked Sto… 2025年05月15日 16時00分

TOKYO, May 15, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “the Company”) announced that at the meeting of the Board of Directors held today, a resolution was passed to continue the Performance-linked Stock Compensation Scheme for the Corporate Executives (Tantou-Yakuin) of the Company and the Performance-linked Stock Delivery Scheme for the domestic and global Astellas Group executives (both schemes hereinafter referred to as the “Schemes”). The Board of Directors also passed a resolution of the details of the incentive plan to be implemented in fiscal year 2025 based on the Schemes (hereinafter the “Plan”) as described below.1. Objective for the Schemes(1) The Schemes are medium- to long-term-based incentive plan, common on a global basis, for the Corporate Executives (Tantou-Yakuin) of the Company and the domestic and global Astellas Group executives that is highly transparent and objective, and closely linked with the Company’s enterprise and shareholder value with the aim of promoting management focused on increasing enterprise and shareholder value over the medium- to long-term.(2) The Performance-linked Stock Compensation Scheme for Corporate Executives (Tantou-Yakuin) of the Company adopts a structure called the executive compensation BIP (Board Incentive Plan) trust (“BIP Trust”). BIP Trust is an executive incentive plan modeled on Performance Share and Restricted Stock systems in the U.S. The BIP Trust acquires the Company’s shares and conducts a “delivery of the Company’s shares” (as set forth in 3. (5) below; hereinafter the same) to the Corporate Executives (Tantou-Yakuin) based on the level of growth of enterprise and shareholder value, etc.The Performance-linked Stock Delivery Scheme for the domestic and global Astellas Group executives adopts a structure called the stock-delivery ESOP (Employee Stock Ownership Plan) trust (“ESOP Trust”). ESOP Trust is an employee incentive plan modeled on the ESOP scheme in the U.S. The ESOP Trust acquires the Company’s shares and conducts a “delivery of the Company’s shares” to the domestic and global Astellas Group executives based on the level of growth of enterprise and shareholder value, etc. 2. The Structure of the BIP Trust and ESOP Trust 1) The Company and the Astellas Group companies shall carry out necessary processes such as holding meetings of the Board of Directors, for continuing the Performance-linked Stock Compensation Scheme and the Performance-linked Stock Delivery Scheme, and the implementation and details of the Plan based on the Schemes.2) The Company shall put money in trust, to establish the BIP Trust, which shall be the trust in which the beneficiaries shall be the Corporate Executives (Tantou-Yakuin)  of the Company who have satisfied the beneficiary conditions, and the ESOP Trust, which shall be the trust in which the beneficiaries shall be the domestic and global Astellas Group executives who have satisfied the beneficiary conditions (BIP Trust and ESOP Trust hereinafter collectively referred to as the “Trust.”) The Company and the domestic and global Astellas Group companies shall contribute a suitable amount to the trust based on the number of eligible persons in the respective company.3) The Trust, in accordance with the instructions of the trust administrator, will use the money entrusted in 2) to acquire the Company’s shares on the stock market.4) Dividends for the Company’s shares in the Trust will be paid in the same way as with other shares of the Company.5) Voting rights are not to be exercised on the Company’s shares within the Trust throughout the trust period.6) During the trust period, beneficiaries will receive delivery of the Company’s shares in accordance with the Company’s Share Delivery Policy.7) In the event that residual shares remain at the expiration of the trust period mainly due to the extent to which enterprise and shareholder value have achieved growth during the trust period, the Trust will continue to be used as an incentive plan based on the Schemes by making changes to the trust agreement and additional entrustments (*1), or otherwise a gratis transfer of these residual shares will be made from the Trust to the Company, and upon acquiring these shares the Company plans to implement the cancellation of them by resolution of the Board of Directors.8) Upon conclusion of the Trust, the residual assets remaining after allocation to the beneficiaries are to belong to the Company within the scope of the reserve fund for trust expenses after deductions for stock purchases from trust money. In the event that there remain residual assets beyond the scope of the reserve fund for trust expenses, such assets are to be donated to an organization having no relationship of interest with the Company or Corporate Executives (Tantou-Yakuin) and executives of the Company.(*1) As the Plan for which Corporate Executives (Tantou-Yakuin) of the Company are eligible are the same kind of incentive plan as the Performance-linked Stock Compensation Scheme introduced in fiscal year 2015, the existing executive compensation BIP for the Corporate Executives (Tantou-Yakuin) that was established in fiscal year 2022 shall continue to be used. In addition, since this plan is an incentive plan similar to the Performance-linked Stock Compensation Scheme that has been implemented since the fiscal year 2020, we will continue to utilize the existing ESOP trust established for domestic and global Astellas Group executives in the fiscal year 2022. 3. Details of the Plan(1) Overview of the PlanThe Plan is an incentive plan, under which delivery of the Company’s shares will be conducted during the three-year period from the fiscal year ending March 31, 2026 to the fiscal year ending March 31, 2028 (“Applicable Period”), based on the level of growth of enterprise and shareholder value, etc.The Company intends to continue implementing incentive plans which are similar to the Plan in each year in and after the following fiscal year by establishing new BIP Trusts or ESOP Trusts, or by making changes or additional entrustments to the existing BIP Trusts or ESOP Trusts that have expired. The details of incentive plans put into effect next fiscal year or later shall be determined at the appropriate time by resolution of the Board of Directors.(2) Individuals eligible under the Plan (Beneficiary Conditions)The Corporate Executives (Tantou-Yakuin) of the Company and the domestic and global Astellas Group executives in office as of April 1, 2025 (“Eligible Individuals”) shall, in principle, receive delivery of a certain number of the Company’s shares based on the points provided for below in (4) subject to the condition that the Beneficiary Conditions set forth below are satisfied.The Beneficiary Conditions are as follows:1) Such person shall be an Eligible Individual at the expiration date of the Applicable Period.2) Such person shall have met other criteria which are deemed necessary for achieving the purpose of the Schemes.(3) Trust periodThe trust period of this trust shall be from May 21, 2025 (planned) to August 31, 2028 (planned). At the expiration of the trust periods, the Company may continue the Trust in the form of incentive plans which are similar to the Plan by making changes to the trust agreements and making additional entrustments.(4) Number of the Company’s shares to be delivered to Eligible IndividualsThe number of the Company’s shares to be delivered to Eligible Individuals (including the number of the Company’s shares to be converted into cash in accordance with (5) below) shall be determined on the basis of the points, which have been allocated in accordance with the following, with 1 point corresponding to 1 share of the Company’s share (*2).(*2) In the event that the number of the Company’s shares belonging to the Trust increases or decreases due to stock split, gratis allotment or stock consolidation, etc., the number of the Company’s shares to be delivered per point shall be adjusted by means of a reasonable method.Basic points shall be allocated to the Eligible Individuals who are in office as of April 1, 2025 in accordance with the following formula.(Formula for the calculation of basic points)Basic amount (*3) individually determined based on rank, global grade, etc. divided by the Average closing price of the Company’s shares on the Tokyo Stock Exchange in March 2025* Any fractions of less than one shall be discarded.(*3) The basic amount levels shall be set appropriately in accordance with responsibilities and other factors in reference particularly to objective remuneration survey data of an external expert organization in order to ensure competitive remuneration levels that enable the Company to recruit and retain talents.Eligible Individuals who are in office as of March 31, 2028 shall receive delivery of the Company’s shares from the Trust in numbers corresponding to the points calculated according to the formula below.Basic points × Performance-linked coefficient (*4)* Any fractions of less than one shall be discarded.(*4) The performance-linked coefficient of the Plan shall be determined within a range from 0% to 200% based on results of comparing the Company’s total shareholder return (“TSR*”) during the applicable period, against both the growth rate of Tokyo Stock Price Index (TOPIX) and the TSR of global pharmaceutical companies (“TSR Peer Group”). The list of the TSR Peer Group shall be proposed to the Board of Directors after deliberation by the Compensation Committee, and accordingly determined by June 30, 2025.* TSR refers to shareholders’ total return on investment, encompassing both capital gains and dividends.(5) Method and timing for delivering the Company’s shares to the Eligible Individuals“Delivery of the Company’s shares” refers to, at a given time, the receipt of half of the number of the Company’s shares corresponding to the allocated points from the Trust (provided that shares less than one unit shall be converted into cash within the Trust and the cash equivalent to the amount of conversion will be received), and the receipt of the cash equivalent to the remaining half after conversion into cash within the Trust.Eligible Individuals who have met the Beneficiary Conditions shall receive delivery of the Company’s shares around June 2028.(6) Malus Clause and Clawback ClauseThe Company and its Group companies stipulate a Malus Clause that forfeits the right to receive delivery of the Company’s shares, by resolution of the Company and its Group companies in the event of misconduct, etc., by Eligible Individuals and the Company stipulates a Clawback Clause which allows to demand the return of the amount equivalent to the number of Company’s shares delivered to Eligible Individuals who are pre-defined by the Company (limited to high-level positions, such as Top Management, etc.), in the event of post-financial restatement due to material accounting errors or fraud, or in the event of misconduct, etc., by Eligible Individuals, by resolution of Board of Directors. The remuneration that may be subject to reimbursement are part or all of the amount equivalent to the number of Company’s shares delivered for the target period that includes the fiscal year in which such event occurred and the three preceding fiscal years.(7) Acquiring the Company’s shares by the TrustIn continuing this Schemes, no additional acquisition of the Company’s shares from the stock market will be made by the Trust.(8) Exercise of voting rights of the Company’s shares within the TrustIn order to maintain a neutral position vis-a-vis management, no voting rights shall be exercised on the Company’s shares within the Trust during the trust period.(9) Handling of dividends on the Company’s shares within the TrustDividends on the Company’s shares within the Trust shall be received by the Trust and applied to trust fees and trust expenses for the Trust.(10) Handling at the expiration of the trust periodIn the event that residual shares remain at the expiration of the trust period due to factors such as the extent to which enterprise and shareholder value have achieved growth during the applicable period, the Company may continue the Trust in the form of incentive plans which are similar to the Plan by making changes to the trust agreement and additional entrustments. If the Trust is to be terminated due to the expiration of the trust period, gratis transfer of these residual shares will be made from the Trust to the Company, and the Company plans to implement the cancellation of them by resolution of the Board of Directors.Additionally, in the event that residual dividends on the Company’s shares within the Trust remain at the expiration of the trust period and the Company continues to use the Trust, such residual assets shall be applied towards the acquisition of shares. However, if the Company concludes the Trust due to the expiration of the trust period, such assets are planned to be donated to an organization having no relationship of interest with the Company or Corporate Executives (Tantou-Yakuin) and executives of the Company.(Reference)[Contents of the Trust for the Incentive Plan in fiscal year 2025] “BIP Trust”“ESOP Trust”1) Trust categoryMonetary trust other than a specific individually operated monetary trust (third-party benefit trust)2) Trust objectiveTo provide incentive to Corporate Executives (Tantou-Yakuin) of the CompanyTo provide incentive to the domestic and global Astellas Group executives3) SettlorThe Company4) TrusteeMitsubishi UFJ Trust and Banking Corporation (planned)(Joint Trustee: The Master Trust Bank of Japan, Ltd.)5) BeneficiariesCorporate Executives (Tantou-Yakuin) of the Company who have satisfied the Beneficiary ConditionsThe domestic and global Astellas Group executives who have satisfied the Beneficiary Conditions6) Trust administratorThird party with no relationship of interest with the Company (certified public accountant)7) Date of trust agreementMay 21, 2025 (planned)8) Trust periodMay 21, 2025 (planned) to August 31, 2028 (planned)9) Start of the PlanApril 1, 202510) Exercise of voting rightsNot to be exercised11) Type of shares to be acquiredCommon stock of the Company12) Amount of entrustment¥378 million (planned)(Including trust fees and trust expenses) (*5)¥3,750 million (planned)(Same as on the left) (*6)13) Rights holderThe Company14) Residual assetsThe Company, the rights holder, shall receive residual assets within the scope of the reserve fund for trust expenses after deductions of stock purchases from trust money.(*5) The above amount of trust includes the residual assets succeeded from the existing BIP Trust.(*6) The above amount of trust includes the residual assets succeeded from the existing ESOP Trust.*In continuing this Schemes, no additional contributions to the BIP trust and ESOP trust, nor additional acquisitions of the company’s shares from the stock market will be made.About AstellasAstellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com.Cautionary NotesIn this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties.Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. Click below for a copy of the full press release 

Notice Regarding Continuation of the Performance-linked St… 2025年05月15日 16時00分

TOKYO, May 15, 2025– Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “the Company”) today announced that at the meeting of the Board of Directors held today, a resolution was passed to approve the details of the incentive plan (“Plan”) to be implemented in fiscal year 2025 based on the Performance-linked Stock Compensation Scheme (“Scheme”) for the Company’s Directors (excluding outside Directors and Directors who are Audit & Supervisory Committee Members; hereinafter “Directors”) as described below.Objective for the Scheme(1) The Scheme is a medium- to long-term-based incentive plan, for the Directors that is highly transparent and objective, and closely linked with the Company’s enterprise and shareholder value with the aim of promoting management focused on increasing enterprise and shareholder value over the medium- to long-term.(2) The Scheme adopts a structure called the executive compensation BIP (Board Incentive Plan) trust (“BIP Trust”). BIP Trust is an executive incentive plan modeled on Performance Share and Restricted Stock systems in the U.S. The BIP Trust acquires the Company’s shares and conducts a “delivery of the Company’s shares” (as set forth in 3. (5) below; hereinafter the same) to the Directors based on the level of growth of enterprise and shareholder value, etc. The Structure of the BIP Trust 1) Based on the Scheme, the Company shall resolve on the implementation and content of the Plan at the meeting of the Board of Directors.2) The Company will put money in trust, to establish the BIP Trust, which will be the trust in which the beneficiaries shall be the Directors who have satisfied the beneficiary conditions (“Trust”). The money entrusted in the Trust shall be within the scope of approval of the 14th Term Annual Shareholders Meeting. 3) The Trust, in accordance with the instructions of the trust administrator, will use the money entrusted in 2) to acquire the Company’s shares on the stock market.4) Dividends for the Company’s shares in the Trust will be paid in the same way as with other shares of the Company.5) Voting rights are not to be exercised on the Company’s shares within the Trust throughout the trust period.6) During the trust period, beneficiaries will receive delivery of the Company’s shares in accordance with the Company’s Share Delivery Policy.7) In the event that residual shares remain at the expiration of the trust period mainly due to the extent to which enterprise and shareholder value have achieved growth during the trust period, the Trust will continue to be used as an incentive plan based on the Scheme by making changes to the trust agreement and additional entrustments (*1), or otherwise a gratis transfer of these residual shares will be made from the Trust to the Company, and upon acquiring these shares the Company plans to implement the cancellation of them by resolution of the Board of Directors.8) Upon conclusion of the Trust, the residual assets remaining after allocation to the beneficiaries are to belong to the Company within the scope of the reserve fund for trust expenses after deductions for stock purchases from trust money. In the event that there remain residual assets beyond the scope of the reserve fund for trust expenses, such assets are to be donated to an organization having no relationship of interest with the Company or Directors and Corporate Executives of the Company.(*1) As the Plan are the same kind of incentive plan as the Performance-linked Stock Compensation Scheme introduced in fiscal year 2015, the existing BIP for the Company’s Directors that was established in fiscal year 2022 will continue to be used. Details of the Plan(1) Overview of the PlanThe Plan is an incentive plan, under which delivery of the Company’s shares will be conducted during the three-year period from the fiscal year ending March 31, 2026 to the fiscal year ending March 31, 2028 (“Applicable Period”), based on the level of growth of enterprise and shareholder value, etc.The Company intends to continue implementing incentive plans which are similar to the Plan in each year in and after the following fiscal year by establishing new BIP Trusts, or by making changes or additional entrustments to the existing BIP Trusts that have expired. The details of incentive plans put into effect next fiscal year or later shall be determined at the appropriate time by resolution of the Board of Directors.(2) Individuals eligible under the Plan (Beneficiary Conditions)The Directors who are in office as of July 1, 2025 (“Eligible Individuals”) will, in principle, receive delivery of a certain number of the Company’s shares based on the points provided for below in (4) subject to the condition that the Beneficiary Conditions set forth below are satisfied.The Beneficiary Conditions are as follows:1) Such person shall continue to serve as the Director until June 1, 2028;2) Such person shall have met other criteria which are deemed necessary for achieving the purpose of the stock compensation scheme.(3) Trust periodThe trust period shall be from May 21, 2025 (planned) to August 31, 2028 (planned).At the expiration of the trust period, the Company may continue the Trust in the form of incentive plans which are similar to the Plan by making changes to the trust agreements and making additional entrustments.(4) Number of the Company’s shares to be delivered to Eligible IndividualsThe number of the Company’s shares to be delivered to Eligible Individuals (including the number of the Company’s shares to be converted into cash in accordance with (5) below) shall be determined on the basis of the points, which have been allocated in accordance with the following, with 1 point corresponding to 1 share of the Company’s share (*2).(*2) In the event that the number of the Company’s shares belonging to the Trust increases or decreases due to stock split, gratis allotment or stock consolidation, etc., the number of the Company’s shares to be delivered per point shall be adjusted by means of a reasonable method.Basic points shall be allocated to the Eligible Individuals who are in office as of July 1, 2025 in accordance with the following formula.(Formula for the calculation of basic points)Basic amount (*3) determined based on rank divided by the Average closing price of the Company’s shares on the Tokyo Stock Exchange in March 2025* Any fractions of less than one shall be discarded.(*3) The basic amount levels shall be set appropriately in accordance with responsibilities and other factors in reference particularly to objective remuneration survey data of an external expert organization in order to ensure competitive remuneration levels that enable the Company to recruit and retain talents.Eligible Individuals who are in office as of June 1, 2028 will receive delivery of the Company’s shares from the Trust in numbers corresponding to the points calculated according to the formula below.Basic points × Performance-linked coefficient (*4)* Any fractions of less than one shall be discarded.(*4) The performance-linked coefficient of the Plan shall be determined within a range from 0% to 200% based on results of comparing the Company’s total shareholder return (“TSR*”) during the applicable period, against both the growth rate of Tokyo Stock Price Index (TOPIX) and the TSR of global pharmaceutical companies (“TSR Peer Group”). The list of the TSR Peer Group shall be proposed to the Board of Directors after deliberation by the Compensation Committee, and accordingly determined by June 30, 2025.*    TSR refers to shareholders’ total return on investment, encompassing both capital gains and dividends.(5) Method and timing for delivering the Company’s shares to the Directors“Delivery of the Company’s shares” refers to, at a given time, the receipt of half of the number of the Company’s shares corresponding to the allocated points from the Trust (provided that shares less than one unit shall be converted into cash within the Trust and the cash equivalent to the amount of conversion will be received), and the receipt of the cash equivalent to the remaining half after conversion into cash within the Trust.Eligible Individuals who have met the Beneficiary Conditions will receive delivery of the Company’s shares around June 2028.In the event that an Eligible Individual retires during the trust period (excluding voluntary retirement and dismissal), as a general rule, such individual will receive the delivery of the Company’s shares in numbers corresponding to the points that have been allocated up to the time of retirement.In the event that an Eligible Individual becomes deceased during the trust period, as a general rule, the Company’s shares shall be converted into cash in numbers corresponding to the points which have been allocated to such individual up to that time within the Trust, and the cash equivalent to the amount of conversion will be received by such individual’s heir from the Trust.(6) Amount expected to be entrusted to the Trust and the number of the Company’s shares expected to be delivered from the Trust (including the number of the Company’s shares to be converted into cash in accordance with (5) above).The Company intends to entrust ¥1,040 million to the Trust (*5).(*5) Equivalent to the total amount of stock purchases, trust fees and trust expenses during the trust period, and inclusive of the residual assets succeeded from the existing BIP Trust. At the 14th Term Annual Shareholders Meeting, it was approved and resolved the maximum amount of contribution to the Scheme to be ¥1,640 million per fiscal year, and the amount to be entrusted by the Company to BIP Trust in each fiscal year shall be within the amount thus resolved.The maximum number of the Company’s shares to be delivered by the Trust during the trust period in accordance with (4) above shall be the number derived by dividing maximum amount of ¥1,640 million entrusted to the Trust by the average closing price of the Company’s shares on the Tokyo Stock Exchange in March 2025.(7) Malus Clause and Clawback ClauseThe Company stipulates in the rules regarding remunerations for Directors a Malus Clause that forfeits the right to receive delivery of the Company’s shares by resolution of the Board of Directors in the event of misconduct, etc. by Eligible Individuals and the Company stipulates a Clawback Clause in the rules regarding remunerations for Directors, which allows the Company to demand the return of the amount equivalent to the number of Company’s shares delivered to Eligible Individuals by resolution of the Board of Directors in the event of post-financial restatement due to material accounting errors or fraud, or in the event of misconduct, etc., by Eligible Individuals. The remuneration that may be subject to reimbursement are part or all of the amount equivalent to the number of Company’s shares delivered, for the target period that includes the fiscal year in which such event occurred and the three preceding fiscal years. (8) Method for acquiring the Company’s shares by the TrustThe acquisition of the Company’s shares by the Trust is planned to be made on the stock market.(9) Exercise of voting rights of the Company’s shares within the TrustIn order to maintain a neutral position vis-a-vis management, no voting rights shall be exercised on the Company’s shares within the Trust during the trust period.(10) Handling of dividends on the Company’s shares within the TrustDividends on the Company’s shares within the Trust shall be received by the Trust and applied to trust fees and trust expenses for the Trust.(11) Handling at the expiration of the trust periodIn the event that residual shares remain at the expiration of the trust period due to factors such as the extent to which enterprise and shareholder value have achieved growth during the applicable period, the Company may continue the Trust in the form of incentive plans which are similar to the Plan by making changes to the trust agreement and additional entrustments. If the Trust is to be terminated due to the expiration of the trust period, gratis transfer of these residual shares will be made from the Trust to the Company, and the Company plans to implement the cancellation of them by resolution of the Board of Directors.Additionally, in the event that residual dividends on the Company’s shares within the Trust remain at the expiration of the trust period and the Company continues to use the Trust, such residual assets shall be applied towards the acquisition of shares. However, if the Company concludes the Trust due to the expiration of the trust period, such assets are planned to be donated to an organization having no relationship of interest with the Company or Directors and Corporate Executives of the Company.  (Reference)[Contents of the Trust for the Incentive Plan in fiscal year 2025]1) Trust categoryMonetary trust other than a specific individually operated monetary trust (third-party benefit trust)2) Trust objectiveTo provide incentive to the Directors3) SettlorThe Company4) TrusteeMitsubishi UFJ Trust and Banking Corporation (planned)(Joint Trustee: The Master Trust Bank of Japan, Ltd.)5) BeneficiariesThe Directors who have satisfied the Beneficiary Conditions6) Trust     administratorThird party with no relationship of interest with the Company (certified public accountant)7) Date of trust agreementMay 21, 2025 (planned)8) Trust periodMay 21, 2025 (planned) to August 31, 2028 (planned)9) Start of the PlanJuly 1, 2025 (planned)10) Exercise of voting rightsNot to be exercised11) Type of shares to be acquiredCommon stock of the Company12) Amount of entrustment¥1,040 million (planned)(Including trust fees and trust expenses) (*6)13) Acquisition period of sharesMay 23, 2025 (planned) to June 30, 2025 (planned)14) Method of acquiring sharesAcquisition on the stock market15) Rights holderThe Company16) Residual assetsThe Company, the rights holder, will receive residual assets within the scope of the reserve fund for trust expenses after deductions of stock purchases from trust money.(*6) The above amount of trust includes the residual assets succeeded from the existing BIP Trust.About AstellasAstellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com.Cautionary NotesIn this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties.Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. Click below for a copy of the full press release 

Cracking the Code to Earlier Bladder Cancer Diagnosis 2025年05月15日 10時00分

Notice of Nominees for Directors 2025年05月07日 18時30分

TOKYO, May 7, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that during a meeting of its Board of Directors held today, it decided a change in Directors as outlined below. The appointment of Andreas Busch and Mark Enyedy as new candidates to be proposed at the 20th Term Annual Shareholders Meeting scheduled for June 19, 2025, represents a significant move in the company's continuous evolution, aimed at enhancing the diverse composition of our Board of Directors. Their extensive experience and insight into the global pharmaceutical industry will further strengthen the board's supervisory function and effectiveness. This decision reflects the voices from stakeholders, including shareholders. The change is subject to approval at the 20th Term Annual Shareholders Meeting and a subsequent decision at the Board of Directors meeting scheduled for the same day.1. Candidates for Directors (excluding Directors who Are Audit & Supervisory Committee Members)Name Current Position (As of May 7)Kenji YasukawaReelectionRepresentative Director, Chairman of the BoardNaoki OkamuraReelectionRepresentative Director, President and CEOKatsuyoshi SugitaReelectionRepresentative Director, Executive Vice President, Chief People OfficerTakashi TanakaOutsideReelectionDirector, Senior Advisor, KDDI CORPORATIONDirector, Okinawa Cellular Telephone CompanyEriko SakuraiOutsideReelectionOutside Director, Sumitomo Mitsui Financial Group, Inc. Outside Director, Kao CorporationOutside Director, Nippon Sheet Glass Company, LtdMasahiro MiyazakiOutsideReelectionOutside Director, Kurita Water Industries Ltd.Yoichi OhnoOutsideReelectionVisiting Professor, Social Medicine, Research Administration Center and Medical Education Center, Saitama Medical UniversityAndreas BuschOutside New CandidateChief Innovation Officer, Absci CorporationMark EnyedyOutside New CandidateNon-Executive Director, BioMarin Pharmaceutical Inc.The current position of the candidates for outside Directors describes significant concurrent positions at other organizations pursuant to the Companies Act.2. Candidates for Directors who Are Audit & Supervisory Committee MembersName Current Position (As of May 7)Rie AkiyamaOutsideReelectionLawyer, Baba & Sawada Law OfficeOutside Director, GOLDWIN INC.The current position of the candidates for outside Directors describes significant concurrent positions at other organizations pursuant to the Companies Act.3. The Board of Directors as from June 19, 2025 (planned)Kenji Yasukawa (Representative Director, Chairman of the Board)Naoki Okamura (Representative Director, President and CEO)Katsuyoshi Sugita (Representative Director, Executive Vice President)Takashi Tanaka (Outside Director)Eriko Sakurai (Outside Director)Masahiro Miyazaki (Outside Director)Yoichi Ohno (Outside Director)Andreas Busch (Outside Director)Mark Enyedy (Outside Director)Rika Hirota (Director, Audit & Supervisory Committee Member)Mika Nakayama (Outside Director, Audit & Supervisory Committee Member) Rie Akiyama (Outside Director, Audit & Supervisory Committee Member)Tomoko Aramaki (Outside Director, Audit & Supervisory Committee Member)<Reference>Brief Biographies of New Candidates for Outside DirectorName: Andreas BuschDate of birth: August 26, 1963Resume, position and responsibilities at the Company:October 1997Head of DG Cardiovascular Diseases, Hoechst Marion Roussel (current Sanofi S.A.)January 1999Vice President, Head of DG Cardiovascular Diseases, Aventis (current Sanofi S.A.),July 2004Global Head of Cardiovascular Research, Sanofi- Aventis (current Sanofi S.A.)May 2005Senior Vice President, Head of Discovery Europe, Bayer HealthCare AG (current Bayer AG)January 2016Head of Drug Discovery, Bayer Pharma AG (current Bayer AG)January 2018Head of R&D and CSO, Shire plcApril 2019Chief Innovation Officer and CSO, Cyclerion Inc. (current Cyclerion Therapeutics Inc.)February 2022Non-Executive Director, Centogene N.V. (current Crown LiquidationCo N.V.)October 2022Chief Innovation Officer, Absci Corporation, (present post)Name: Mark EnyedyDate of birth: December 27, 1963Resume, position and responsibilities at the Company:September 1990Associate, Palmer & Dodge, LLP (current Locke Lord LLP)February 1996Corporate Counsel, Genzyme Corporation (current Sanofi S.A.)November 1999Vice President, Oncology, Business Development, Genzyme Corporation (current Sanofi S.A.)July 2008President, Transplant, Oncology, and Multiple Sclerosis, Genzyme Corporation (current Sanofi S.A.)September 2011Director, Chief Executive Officer, Proteostasis Therapeutics, Inc. (current Janssen Pharmaceutica N.V.)July 2012Non-Executive Director, Fate Therapeutics, Inc.August 2013Head of Business Unit, Internal Medicine, Shire plcMay 2014Head of Corporate Development, Shire plcMay 2016Director, President and Chief Executive Officer, ImmunoGen Inc. (current AbbVie Inc.)September 2017Non-Executive Director, Keryx Biopharmaceuticals, Inc. (current Akebia Therapeutics, Inc.)March 2020Non-Executive Director, LogicBio Therapeutics, Inc. (current Alexion Pharmaceuticals, Inc.)May 2021Non-Executive Director, Ergomed Group Limited (present post)December 2023Non-Executive Director, BioMarin Pharmaceutical Inc. (present post) About AstellasAstellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com.Cautionary NotesIn this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties.Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. Click below for a copy of the full press release