EU clears Merck KEYTRUDA-Padcev bladder combo

Merck has gained European Commission approval for KEYTRUDA (pembrolizumab) in combination with Padcev (enfortumab vedotin-ejfv) as a perioperative treatment for adults with resectable muscle-invasive bladder cancer. The regimen is authorized for use before surgery as neoadjuvant therapy and continued after cystectomy as adjuvant treatment. This decision applies to patients regardless of their eligibility for cisplatin-based chemotherapy. The approval marks a significant expansion of treatment options for this aggressive form of bladder cancer in Europe.

The authorization covers marketing of the KEYTRUDA and Padcev combination for this indication in all 27 European Union member states, as well as Iceland, Liechtenstein and Norway. Timing for commercial availability in individual countries will depend on factors such as completion of national reimbursement procedures. The approval follows a positive opinion from the Committee for Medicinal Products for Human Use issued in September 2026.

KEYTRUDA plus Padcev is the first and only PD-1 inhibitor plus antibody-drug conjugate regimen approved in the European Union for people with muscle-invasive bladder cancer regardless of cisplatin eligibility.

In addition to the EU decision, a related KEYTRUDA-based regimen with enfortumab vedotin-ejfv has been approved in the United States for adults with muscle-invasive bladder cancer regardless of cisplatin eligibility. The convergence of approvals across major markets underlines the growing role of PD-1 inhibitors combined with antibody-drug conjugates in uro-oncology treatment strategies.

The European Commission’s decision is supported by data from the Phase 3 KEYNOTE-B15 trial, also known as EV-304, conducted in collaboration with Pfizer and Astellas. In this study involving cisplatin-eligible patients, the KEYTRUDA and Padcev regimen reduced the relative risk of event-free survival events by 47% compared with chemotherapy followed by surgery. The combination also reduced the risk of death by 35% versus the chemotherapy and surgery control arm.

These results formed the clinical basis for extending use of the regimen to all adults with resectable muscle-invasive bladder cancer, irrespective of cisplatin eligibility. The trial outcomes were cited by Merck as demonstrating a meaningful advance for patients, supporting the adoption of a chemotherapy-free perioperative approach in this disease setting.

The new authorization builds on a prior European Union approval of KEYTRUDA plus Padcev for bladder cancer granted less than six months earlier. With the latest decision, Merck can offer what it describes as a broader treatment option that now includes patients with muscle-invasive disease scheduled for cystectomy. The combination strengthens the company’s position in bladder cancer and expands the indications of KEYTRUDA within its established immuno-oncology franchise.

By enabling use across multiple European markets and associated countries, the approval increases the geographic reach of the KEYTRUDA and Padcev regimen in muscle-invasive bladder cancer. Future uptake will depend on country-level reimbursement and implementation decisions, but the regulatory clearance provides a unified framework for access across the region.