<p>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. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Pfizer Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20251117031627) on November 21, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT)</p>

<p>The FDA has approved Pfizer and Astellas' PADCEV in combination with Keytruda for treating muscle-invasive bladder cancer in patients ineligible for cisplatin chemotherapy. This approval, based on the Phase 3 EV-303 trial, is the first perioperative treatment to show a survival advantage over surgery alone. The approval was granted earlier than expected.</p>

- Pfizer Inc. and Astellas Pharma Inc. announced FDA approval for PADCEV® in combination with Keytruda® as a perioperative treatment for adult patients with muscle-invasive bladder cancer who cannot receive cisplatin chemotherapy.  
- This approval, based on the Phase 3 EV-303 (KEYNOTE-905) clinical trial, is the first to demonstrate a significant survival advantage over surgery alone for this patient group.  
- The approval was granted earlier than expected and was jointly obtained by both companies.

FDA Approves Pfizer and Astellas' PADCEV Plus Keytruda for Bladder Cancer