Pfizer, Astellas announces FDA approval of PADCEV plus Keytruda in MIBC
Pfizer (PFE) and Astellas Pharma (ALPMY) announced that the U.S. Food and Drug Administration has approved PADCEV, a Nectin-4 directed antibody-drug conjugate, plus the PD-1 inhibitor, Keytruda or Keytruda QLEX as neoadjuvant and adjuvant treatment for adult patients with muscle-invasive bladder cancer regardless of cisplatin eligibilityi. This now marks the first platinum-free regimen approved for adult patients with MIBC, regardless of cisplatin eligibility. The approval was based on results from the pivotal Phase 3 EV-304 clinical trial, which were presented at the 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium. This expanded indication builds on the November 2025 U.S. FDA approval of the combination for use as neoadjuvant and adjuvant treatment in cisplatin-ineligible adult patients with MIBC, based on results from the EV-303 Phase 3 clinical trial that were published in the New England Journal of Medicine.
Pfizer (PFE) and Astellas Pharma (ALPMY) announced that the U.S.
Food and Drug Administration has approved PADCEV, a Nectin-4 directed antibody-drug conjugate, plus the PD-1 inhibitor, Keytruda or Keytruda QLEX as neoadjuvant and adjuvant treatment for adult patients with muscle-invasive bladder cancer regardless of cisplatin eligibilityi.
This now marks the first platinum-free regimen approved for adult patients with MIBC, regardless of cisplatin eligibility.
The approval was based on results from the pivotal Phase 3 EV-304 clinical trial, which were presented at the 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium.
This expanded indication builds on the November 2025 U.S.
FDA approval of the combination for use as neoadjuvant and adjuvant treatment in cisplatin-ineligible adult patients with MIBC, based on results from the EV-303 Phase 3 clinical trial that were published in the New England Journal of Medicine.