<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

輝瑞

安斯泰萊制藥(ADR)

默克、輝瑞和安斯泰萊製藥（ADR）已獲得 FDA 對其 Keytruda/Padcev 藥物組合的優先審查，旨在治療肌肉侵襲性膀胱癌。此項認證縮短了審查週期，授予那些可能顯著改善嚴重疾病治療的藥物。FDA 對申請的目標行動日期為 8 月 17 日。如果獲得批准，該方案將成為肌肉侵襲性膀胱癌的首個圍手術期治療，無論患者是否適合使用順鉑，可能會建立新的治療標準

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

- 默克、輝瑞和阿斯利康的藥物組合獲得 FDA 優先審查，用於膀胱癌患者。  
- 新申請旨在擴大 Keytruda/Padcev 組合的適用範圍，為肌侵襲性膀胱癌患者提供新的治療選擇。  
- FDA 預計在 8 月 17 日前做出審批決定，若獲批將樹立新治療標準。

默克、輝瑞和安斯泰萊製藥的藥物組合在膀胱癌治療中獲得 FDA 的快速審查