<div id="readability-page-1"><div> By Colin Kellaher <pre></pre> Merck, Pfizer and Astellas Pharma have won U.S. Food and Drug Administration priority review for their applications seeking expanded approval of their Keytruda/Padcev drug combination in certain patients with a hard-to-treat form of bladder cancer. The companies on Monday said the applications cover Merck's Keytruda and Keytruda QLEX, each coupled with Padcev from Pfizer and Astellas, for the treatment of patients with muscle-invasive bladder cancer who are eligible for cisplatin-based chemotherapy. The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period. The companies said the FDA has set a target action date of Aug. 17 for the applications. The FDA previously approved the combination of Keytruda and Padcev for adults with muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy. The companies said approval of the new applications would make the regimen the first and only perioperative treatment for patients with muscle-invasive bladder cancer regardless of cisplatin eligibility, marking a potential new standard of care. Merck in 2019 signed a deal to evaluate the combination of its blockbuster cancer drug Keytruda with Padcev from Astellas and Seagen, which Pfizer acquired in a $43 billion deal that closed in late 2023. The combination is approved for the treatment of adults with locally advanced or metastatic urothelial cancer in the U.S., the European Union, Japan and several other countries around the world. <pre></pre> Write to Colin Kellaher at colin.kellaher@wsj.com <pre></pre> (END) Dow Jones Newswires April 20, 2026 07:44 ET (11:44 GMT)Copyright (c) 2026 Dow Jones &amp; Company, Inc.</div></div>

默克

辉瑞

安斯泰莱制药(ADR)

默克、辉瑞和安斯泰莱制药（ADR）已获得 FDA 对其 Keytruda/Padcev 药物组合的优先审查，旨在治疗肌肉侵袭性膀胱癌。此项认证缩短了审查周期，授予那些可能显著改善严重疾病治疗的药物。FDA 对申请的目标行动日期为 8 月 17 日。如果获得批准，该方案将成为肌肉侵袭性膀胱癌的首个围手术期治疗，无论患者是否适合使用顺铂，可能会建立新的治疗标准

Merck, Pfizer, Astellas Drug Combo Gets Speedy FDA Review in Bladder Cancer

- 默克、辉瑞和阿斯利康的药物组合获得 FDA 优先审查，用于膀胱癌患者。  
- 新申请旨在扩大 Keytruda/Padcev 组合的适用范围，为肌侵袭性膀胱癌患者提供新的治疗选择。  
- FDA 预计在 8 月 17 日前做出审批决定，若获批将树立新治疗标准。

默克、辉瑞和安斯泰莱制药的药物组合在膀胱癌治疗中获得 FDA 的快速审查