Pfizer says FDA approves Padcev-Keytruda combo for certain patients

Pfizer (PFE) and Astellas Pharma (ALPMY) (ALPMY announced that the U.S. Food and Drug Administration has approved PADCEV, a Nectin-4 directed antibody-drug conjugate, in combination with the PD-1 inhibitor Keytruda or Keytruda QLEX, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment for adult patients with muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy.i The approval of this perioperative treatment was based on results from the pivotal Phase 3 EV-303 clinical trial, which were presented during a Presidential Symposium at the European Society of Medical Oncology Congress 2025.