Merck, Pfizer, Astellas Bladder Cancer Treatment Approved by FDA

By Elias Schisgall


The Food and Drug Administration approved a combination treatment by Merck & Co., Pfizer, and Astellas Pharma for a hard-to-treat form of bladder cancer.

The agency greenlit Merck's Keytruda and its subcutaneous formulation Keytruda QLEX, together with Astellas and Pfizer's Padcev, to treat adults with muscle-invasive bladder cancer who are eligible for cisplatin-based chemotherapy.

The approval comes after the FDA granted priority review for the treatment combination in April. The agency had previously approved the combination for patients who are ineligible for cisplatin-based chemotherapy.

Merck Research Laboratories's head of oncology, Marjorie Green, said the approval represents a new range of options for patients eligible for cisplatin-based chemotherapy.

The results of the companies' studies, Green said, "highlight the potential of these new treatment options for patients regardless of cisplatin eligibility in the perioperative setting and mark a promising step forward in the treatment of muscle-invasive bladder cancer."

Merck signed an agreement to evaluate the Padcev/Keytruda combination in 2019. Padcev was developed by Astellas and Seagen, which was acquired by Pfizer for $43 billion in 2023.


Write to Elias Schisgall at elias.schisgall@wsj.com


(END) Dow Jones Newswires

July 10, 2026 14:56 ET (18:56 GMT)

Copyright (c) 2026 Dow Jones & Company, Inc.

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