PADCEV (enfortumab vedotin-ejfv) plus KEYTRUDA (pembrolizumab) - (KEYNOTE-B15/EV-304)

July 10, 2026: Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503) announced the FDA approved PADCEV (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab) or Keytruda QLEX (pembrolizumab and berahyaluronidase alfa-pmph) as neoadjuvant and adjuvant (perioperative) treatment for adults with muscle-invasive bladder cancer (MIBC), regardless of cisplatin eligibility. The companies describe it as the first FDA-approved platinum-free regimen for this setting.

The expanded approval is based on the Phase 3 EV-304/KEYNOTE-B15 trial in cisplatin-eligible MIBC, presented at the 2026 ASCO Genitourinary Cancers Symposium. Versus neoadjuvant gemcitabine/cisplatin plus surgery, PADCEV+pembrolizumab plus surgery improved event-free survival (HR 0.53; 95% CI 0.41–0.70; 1-sided p<0.0001), with 2-year event-free rates 79.4% vs 66.2%, improved overall survival (HR 0.65; 95% CI 0.48–0.89; 1-sided p=0.0029), and increased pathologic complete response at surgery (55.8% vs 32.5%; 1-sided p<0.0001). Safety was consistent with prior experience; grade ≥3 AEs occurred in 75.7% vs 67.2% with chemotherapy.

The release notes a prior FDA approval in November 2025 for cisplatin-ineligible MIBC based on EV-303/KEYNOTE-905.