Pfizer Inc. and Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has approved PADCEV® (enfortumab vedotin-ejfv) in combination with the PD-1 inhibitor Keytruda® (pembrolizumab) as a perioperative treatment regimen for adult patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy. This approval, granted earlier than anticipated, is based on results from the Phase 3 EV-303 (KEYNOTE-905) clinical trial and marks the first FDA-approved perioperative treatment to show a meaningful survival advantage over surgery alone in this patient group. The approval was jointly obtained by Pfizer Inc. and Astellas Pharma Inc.
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