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FDA Approves Merck's Keytruda with Astellas's Padcev to Treat Bladder Cancer

Provided by Dow Jones Nov 21, 2025, 6:07:00 PM

By Kelly Cloonan

The Food and Drug Administration approved Merck's Keytruda in combination with Astellas's Padcev to treat certain adults with muscle invasive bladder cancer (MIBC).

The FDA said Friday it has approved the drug combination as a treatment for before and after bladder-removal surgery in adult MIBC patients who are ineligible for cisplatin, a chemotherapy medication.

A recent trial demonstrated statistically significant improvements in event-free survival and overall survival for patients with previously untreated MIBC who were treated with the drug combination before and after bladder-removal surgery and pelvic lymph node dissection, compared with surgery alone, the FDA said.

Write to Kelly Cloonan at kelly.cloonan@wsj.com

(END) Dow Jones Newswires

November 21, 2025 13:07 ET (18:07 GMT)

Copyright (c) 2025 Dow Jones & Company, Inc.

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