FDA Approves Padcev for Muscle-Invasive Bladder Cancer

TUESDAY, Dec. 2, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has approved Padcev (enfortumab vedotin-ejfv), a Nectin-4 directed antibody-drug conjugate, as a perioperative neoadjuvant treatment and postcystectomy adjuvant treatment for adult patients with muscle-invasive bladder cancer (MIBC).Padcev is approved for use in combination with the programmed death 1 inhibitor Keytruda (pembrolizumab) or Keytruda QLEX (pembrolizumab and berahyaluronidase alfa-pmph) as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment for adult patients with MIBC who are ineligible for cisplatin-containing chemotherapy. The approval is based on the phase 3 KEYNOTE-905 study, in which patients were randomly assigned to receive either neoadjuvant and adjuvant pembrolizumab (arm A), surgery alone (arm B), or neoadjuvant and adjuvant Padcev in combination with pembrolizumab (arm C).Compared with surgery alone, perioperative treatment with Padcev plus pembrolizumab resulted in a 60 percent reduction in the risk for tumor recurrence, progression, or death, meeting the primary end point of event-free survival (EFS; hazard ratio, 0.40). The estimated median EFS was 15.7 months for the surgery arm and has not yet been reached for the combination arm. Perioperative treatment with Padcev plus pembrolizumab resulted in a 50 percent reduction in the risk for death versus surgery alone (hazard ratio, 0.50), with a probability of survival at two years of 79.7 percent for patients who received the combination versus 63.1 percent for patients treated with surgery only. The estimated median overall survival was 41.7 months for the surgery arm and has not yet been reached for the combination arm."Half of patients with MIBC may experience cancer recurrence even after having their bladder removed, and many of these patients are ineligible to receive cisplatin," Matthew Galsky, M.D., from the Mount Sinai Tisch Cancer Center in New York City, and a KEYNOTE-905 investigator, said in a statement. "This approval, based on striking event-free and overall survival benefits, may represent an important practice-changing advance for these patients who’ve had no new options in decades."Approval of Padcev was granted to Pfizer and Astellas.More Information.Sign up for our weekly HealthDay newsletter

FDA Approves Padcev for Muscle-Invasive Bladder Cancer

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