02:20 PM EST, 11/21/2025 (MT Newswires) -- Pfizer ( PFE ) and Astellas Pharma said Friday the US Food and Drug Administration approved Padcev in combination with Merck's ( MRK ) Keytruda as a perioperative treatment for adults with muscle-invasive bladder cancer who cannot take cisplatin chemotherapy.

The approval is based on results from the ongoing phase 3 EV-303 trial, which showed a 60% reduction in the risk of disease recurrence, progression or death, and a 50% reduction in the risk of death, compared with surgery alone.

Pfizer ( PFE ), which acquired Seagen on Dec. 14, 2023, and Astellas had previously collaborated with Merck ( MRK ) to evaluate Padcev, or enfortumab vedotin-ejfv, with Keytruda in this indication.

Shares of Pfizer ( PFE ) rose 3.7% and Merck ( MRK ) was up 5% in recent trading.

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