Merck, known as MSD outside the United States and Canada, announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Keytruda (pembrolizumab) in combination with Padcev (enfortumab vedotin-ejfv) as a perioperative treatment for adults with resectable Muscle-Invasive Bladder Cancer (MIBC).

Under the proposed indication, Keytruda plus Padcev would be administered as neoadjuvant treatment before radical cystectomy and continued as adjuvant treatment following surgery. The recommendation also covers Keytruda SC, known as Keytruda Qlex in the United States. The recommendation will now be reviewed by the European Commission (EC) for marketing authorisation in the European Union, Iceland, Liechtenstein and Norway, with a final decision expected in the fourth quarter of 2026.

The CHMP recommendation is based on results from the Phase 3 KEYNOTE-B15 trial, also known as EV-304, conducted in collaboration with Pfizer and Astellas. The trial evaluated Keytruda plus Padcev as perioperative treatment against neoadjuvant gemcitabine and cisplatin followed by surgery in patients with MIBC who were eligible for cisplatin-based chemotherapy. 

In the study, Keytruda plus Padcev reduced the risk of event-free survival (EFS) events by 47 percent, with an EFS hazard ratio of 0.53. EFS events occurred in 21 percent of patients receiving the combination compared with 36 percent in the chemotherapy and surgery group.

The combination also reduced the risk of death by 35 percent, with an overall survival hazard ratio of 0.65 (95% CI, 0.48-0.89; p=0.0029). Death occurred in 17 percent of patients in the Keytruda plus Padcev group compared with 25 percent in the comparator group.

Keytruda plus Padcev also produced a higher pathologic complete response (pCR) rate, at 55.8 percent, compared with 32.5 percent for neoadjuvant chemotherapy, with the difference reaching statistical significance. 

If approved by the European Commission, the combination would expand the existing European indication for Keytruda plus Padcev in MIBC. In June 2026, the EC approved the regimen for adults with resectable MIBC who are ineligible for cisplatin-containing chemotherapy, based on results from the Phase 3 KEYNOTE-905 trial.

The latest CHMP recommendation would remove the cisplatin-eligibility restriction from the indication, covering adults with resectable MIBC. The EMA confirmed that its September 2026 CHMP meeting adopted positive opinions for extensions of indication for both Keytruda and Padcev. 

In the United States, the FDA approved Keytruda and Keytruda Qlex, each in combination with Padcev, as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with MIBC in July 2026. The approvals were based on the KEYNOTE-B15 results together with the earlier KEYNOTE-905 data.