Posted by Michael Wonder on 21 Apr 2026
US FDA grants priority review to sBLA for Padcev and Keytruda as peri-operative treatment for muscle invasive bladder cancer regardless of cisplatin eligibility
20 April 2026 - Astellas Pharma and Pfizer announced that the US FDA accepted for triority review a supplemental biologics license application 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 peri-operative treatment in cisplatin-ineligible patients with MIBC. This filing seeks to expand the indication to patients with MIBC regardless of cisplatin eligibility.
Under the PDUFA, the FDA has set a target action date of 17 August 2026.
