Pfizer, Astellas Expand PADCEV-Keytruda Label With FDA Nod In Bladder Cancer - Pfizer (NYSE:PFE)

On Friday, the U.S. Food and Drug Administration (FDA) approved Pfizer Inc.’s (NYSE:PFE) and Astellas Pharma Inc.’s (OTC:ALPMF) (OTC:ALPMY) PADCEV (enfortumab vedotin-ejfv) combo regimen for bladder cancer.

The approval covers PADCEV in combination with Keytruda (pembrolizumab) or Keytruda QLEX (pembrolizumab and berahyaluronidase alfa-pmph) as neoadjuvant and adjuvant treatment for adults with muscle-invasive bladder cancer (MIBC), regardless of their eligibility for cisplatin.

The decision makes the combination the first platinum-free regimen approved for this patient population.

Phase 3 Trial Supported Expanded Approval

The FDA’s expanded approval was supported by findings from the Phase 3 EV-304 trial, also known as KEYNOTE-B15, which were presented at the 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium.