• First and only treatment regimen for adults with MIBC, regardless of cisplatin eligibility, representing a platinum-free potential standard of care
  • Broadened approval supported by Phase 3 EV-304 data showing a nearly 50% reduction in the risk of tumor recurrence, progression or death, and a 35% reduction in the risk of death, versus standard of care in cisplatin-eligible patients 

Pfizer Inc. (NYSE:PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has approved PADCEV® (enfortumab vedotin-ejfv), a Nectin-4 directed antibody-drug conjugate, plus the PD-1 inhibitor, Keytruda® (pembrolizumab) or Keytruda QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) as neoadjuvant and adjuvant (before and after surgery) 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.

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The approval was based on results from the pivotal Phase 3 EV-304 clinical trial (also known as KEYNOTE-B15), which were presented at the 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU). 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 (also known as KEYNOTE-905) that were published in the New England Journal of Medicine.