• Submission based on statistically significant event-free and overall survival data from the Phase 3 EV-304 trial
  • Building on the existing indication in cisplatin-ineligible muscle-invasive bladder cancer (MIBC), if approved, this regimen would be the first and only perioperative treatment for patients with MIBC regardless of cisplatin eligibility, marking a potential new standard of care

TOKYO and NEW YORK, April 20, 2026 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Pfizer Inc. (NYSE:PFE) announced that the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental Biologics License Application (sBLA) for perioperative (before and after surgery) PADCEV™ (enfortumab vedotin-ejfv), a Nectin-4 directed antibody-drug conjugate, in combination with the PD-1 inhibitor Keytruda® (pembrolizumab) or Keytruda QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) as treatment for patients with muscle-invasive bladder cancer (MIBC). This regimen was FDA-approved in November 2025 for use as perioperative treatment in cisplatin-ineligible patients with MIBC. This filing seeks to expand the indication to patients with MIBC regardless of cisplatin eligibility. The FDA grants Priority Review to medicines that may offer significant advances in treatment or may provide a treatment where limited therapy options exist.i Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of August 17, 2026.