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

By Colin Kellaher

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.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

April 20, 2026 07:44 ET (11:44 GMT)