Merck said the European Commission has approved KEYTRUDA (pembrolizumab) in combination with Padcev (enfortumab vedotin‑ejfv) as a perioperative regimen for adults with resectable muscle‑invasive bladder cancer (MIBC) who are ineligible for cisplatin‑containing chemotherapy. The decision covers use of the combination as neoadjuvant treatment before radical cystectomy and as adjuvant treatment afterward. It applies to both intravenous KEYTRUDA and the subcutaneous formulation KEYTRUDA SC (known as KEYTRUDA QLEX in the U.S.). The authorization makes the pairing the first and only PD‑1 inhibitor plus antibody‑drug conjugate regimen available for this patient group in the European Union.
The approval is based on results from the pivotal Phase 3 KEYNOTE‑905 (EV‑303) trial, conducted with Pfizer and Astellas, which compared the perioperative KEYTRUDA–Padcev regimen with surgery alone in patients with resectable MIBC who were either cisplatin‑ineligible or declined cisplatin‑based chemotherapy. In the study, the combination demonstrated statistically significant and clinically meaningful improvements in event‑free survival (EFS), overall survival (OS) and pathologic complete response (pCR) rates versus cystectomy alone. KEYTRUDA plus Padcev reduced the risk of EFS events by 60% (hazard ratio 0.40; 95% CI 0.28–0.57; p<0.0001), with median EFS not reached (95% CI 37.3–not reached) compared with 15.7 months (95% CI 10.3–20.5) for surgery alone.
Overall survival also favored the combination, which cut the risk of death by 50% (hazard ratio 0.50; 95% CI 0.33–0.74; p=0.0002). Median OS was not reached for patients receiving KEYTRUDA and Padcev (95% CI not reached–not reached), versus 41.7 months (95% CI 31.8–not reached) for those undergoing surgery alone. The trial showed a marked difference in pCR rates at cystectomy: 57.1% (95% CI 49.3–64.6) with the combination versus 8.6% (95% CI 4.9–13.8) with surgery alone (p<0.0001). Investigators described the perioperative regimen as a potential practice‑changing option for a group that has historically had few effective therapies beyond surgery.
With this decision, the KEYTRUDA–Padcev regimen is authorized for marketing in all 27 EU member states as well as Iceland, Liechtenstein and Norway. Actual timing of commercial availability in individual countries will depend on national reimbursement and implementation processes. The European approval follows a positive opinion from the Committee for Medicinal Products for Human Use issued in May 2026 and builds on U.S. approvals granted in November 2025, when KEYTRUDA and KEYTRUDA QLEX, each with Padcev, were cleared by the FDA as neoadjuvant and adjuvant treatment for cisplatin‑ineligible adults with MIBC undergoing cystectomy.
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