On 20 April 2026, Astellas Pharma and Pfizer announced that the FDA granted priority review of the sBLA for Astella Pharma/Pfizer’s Padcev™ (enfortumab vedotin-ejfv) in combination with MSD’s Keytruda® (pembrolizumab) or Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph), for the treatment of muscle-invasive bladder cancer (MIBC), regardless of cisplatin eligibility.
The combination received FDA approval in November 2025 for cisplatin-ineligible patients with MIBC. The sBLA seeks to expand the indication to patients regardless of cisplatin eligibility
The FDA has set a target action date under the Prescription Drug User Fee Act of 17 August 2026.