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FDA Grants Priority Review for Pfizer and Astellas' Padcev with Keytruda for Bladder Cancer
The FDA has granted priority review for Pfizer and Astellas’ marketing application of Padcev in combination with Merck’s Keytruda for bladder cancer, aiming to broaden its use to all muscle-invasive bladder cancer patients. This application is supported by successful Phase 3 EV-304 trial data, which showed improved event-free survival. The FDA’s target action date is August 17, 2026, with potential approval expected to expand treatment options and strengthen the companies’ oncology market presence.