Merck gains EU approval for Keytruda plus Padcev in bladder cancer

• Merck (NYSE:MRK) received European Union approval for KEYTRUDA plus Padcev as perioperative treatment for resectable muscle-invasive bladder cancer in cisplatin-ineligible patients.
• The combination is the first PD-1 inhibitor plus antibody-drug conjugate regimen approved in the EU for this indication.
• Merck stated the approval is based on the KEYNOTE-905 trial showing significant improvements in event-free survival, overall survival, and pathologic complete response.

Merck (NYSE:MRK) announced that the European Commission approved KEYTRUDA (pembrolizumab), in combination with Padcev (enfortumab vedotin-ejfv), as neoadjuvant treatment followed by adjuvant treatment after radical cystectomy for adults with resectable muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy.

The approval covers KEYTRUDA SC (also known as KEYTRUDA QLEX in the U.S.) and makes this the first PD-1 inhibitor plus antibody-drug conjugate regimen available for these patients in the EU.

“This approval marks a turning point in bladder cancer care,” said Professor Christof Vulsteke, head of Integrated Cancer Center Ghent and KEYNOTE-905 principal investigator.

The approval was based on the Phase 3 KEYNOTE-905 trial, which showed KEYTRUDA plus Padcev reduced the risk of event-free survival events by 60% and the risk of death by 50% versus surgery alone.

The combination also achieved a pathologic complete response rate of 57.1% versus 8.6% for surgery alone.

This approval applies to all 27 EU member states plus Iceland, Liechtenstein, and Norway.

Merck noted that timing for commercial availability will depend on national reimbursement procedures in individual countries.

Merck continues to expand the use of KEYTRUDA across multiple cancer types through combinations with other therapies, including antibody-drug conjugates, to address high unmet needs in oncology.

The company previously received FDA approval for this combination in the United States in November 2025.