PADCEV™ (enfortumab vedotin-ejfv) Plus KEYTRUDA® (pembrolizumab) sBLA Granted FDA Priority Review for Treatment of Certain Patients with Muscle

Results from the pivotal EV-303 trial demonstrated that, when used before and after surgery, the combination reduced the risk of recurrence, progression or death by 60% and the risk of death by 50% in cisplatin-ineligible patients with muscle-invasive bladder cancer

If approved, PADCEV plus KEYTRUDA could fundamentally change the treatment approach for patients with this disease

TOKYO , Oct. 22, 2025 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) accepted for priority review a supplemental Biologics License Application (sBLA) for PADCEV™ (enfortumab vedotin-ejfv) in combination with KEYTRUDA ® (pembrolizumab) as a neoadjuvant treatment (before surgery) and then continued after