Merck's Keytruda-Padcev Combo Clears EU Regulatory Hurdle
Merck's Keytruda-Padcev combo has cleared a key hurdle in Europe, after receiving a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). This combination therapy is being considered for adults with resectable muscle-invasive bladder cancer.
The CHMP recommendation covers the use of Keytruda (pembrolizumab) with Padcev (enfortumab vedotin-ejfv) before surgery and continued after radical cystectomy as adjuvant treatment. The European Commission will review this recommendation, with a final decision expected in the fourth quarter of 2026.
The combination has shown significant improvement in event-free survival and overall survival compared to neoadjuvant chemotherapy followed by surgery. In the Phase 3 KEYNOTE-B15 trial, the Keytruda-Padcev regimen reduced the risk of an event by 47% and death by 35%. The pCR rate was also substantially improved at 55.8%
The latest recommendation builds on a regulatory expansion already secured in Europe. In June 2026, the European Commission approved Keytruda in combination with Padcev for neoadjuvant and subsequent adjuvant treatment of adults with resectable MIBC who are ineligible for cisplatin-containing chemotherapy.