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

April 20, 2026: Astellas Pharma Inc. (TSE: 4503) and Pfizer Inc. (NYSE: PFE) said the FDA accepted for Priority Review a supplemental BLA seeking to expand perioperative PADCEV (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab) / Keytruda QLEX (pembrolizumab and berahyaluronidase alfa-pmph) for muscle-invasive bladder cancer (MIBC) to patients regardless of cisplatin eligibility. The regimen was approved in November 2025 as perioperative treatment for cisplatin-ineligible MIBC. The PDUFA target action date is August 17, 2026.

The sBLA is supported by the Phase 3 EV-304 (KEYNOTE-B15) trial in cisplatin-eligible MIBC comparing perioperative enfortumab vedotin + pembrolizumab vs neoadjuvant gemcitabine/cisplatin. Results presented at the 2026 ASCO GU Symposium showed a 47% reduction in risk of recurrence/progression/death (EFS) and a 35% reduced risk of death (OS), with pCR 55.8% vs 32.5% at surgery. Safety was consistent with prior experience with no new safety signals. The companies plan to discuss EV-304 data with additional global regulators for potential filings.