EU Approves Keytruda and Padcev for Muscle-Invasive Bladder Cancer

The European Commission has approved Merck’s Keytruda (pembrolizumab) in combination with Padcev (enfortumab vedotin-ejfv) as a perioperative treatment for adults with resectable muscle-invasive bladder cancer (MIBC). The approval provides a new treatment option for patients regardless of their eligibility for cisplatin-based chemotherapy.

Announced on October 21, 2026, the approval covers treatment before surgery, followed by continued treatment after radical cystectomy, a surgical procedure to remove the bladder. The decision also includes Keytruda SC, the subcutaneous formulation of pembrolizumab.

Merck, known as MSD outside the United States and Canada, said the combination is the first and only programmed death-1 (PD-1) inhibitor and antibody-drug conjugate (ADC) regimen approved in the European Union for this patient population, regardless of cisplatin eligibility.

The approval is based on results from the Phase 3 KEYNOTE-B15 trial, also known as EV-304, conducted in collaboration with Pfizer and Astellas. The study enrolled 808 patients with previously untreated muscle-invasive bladder cancer who were eligible for cisplatin-based chemotherapy.

In the trial, Keytruda plus Padcev reduced the risk of disease progression, cancer recurrence or death by 47% compared with standard chemotherapy followed by surgery. The combination also reduced the risk of death by 35% and achieved a higher rate of pathological complete response, meaning no signs of cancer were found in the tissue examined after treatment.

The pathological complete response rate was 55.8% among patients receiving Keytruda plus Padcev, compared with 32.5% among those receiving gemcitabine and cisplatin followed by surgery.

The treatment combination offers an alternative to conventional chemotherapy for eligible patients. Cisplatin-based chemotherapy followed by surgery has been a standard approach for muscle-invasive bladder cancer, but recurrence remains a concern. In addition, some patients cannot receive cisplatin because of their health or other clinical factors, leaving them with fewer treatment options.

The European Commission’s decision authorises the treatment across all 27 EU member states, as well as Iceland, Liechtenstein and Norway. However, the timing of commercial availability in individual countries will depend on national reimbursement and other local procedures.

The combination was previously approved by the US Food and Drug Administration in July 2026 for adults with muscle-invasive bladder cancer, based on the KEYNOTE-B15 trial.

The latest European approval expands treatment options for patients with earlier-stage bladder cancer and highlights the growing role of immunotherapy and antibody-drug conjugates in cancer care. These treatments combine different approaches to target cancer, with the aim of improving outcomes before and after surgery.

Merck continues to study Keytruda across a broad range of cancer types and treatment settings, including earlier stages of disease. The company said its research aims to improve treatment options and address unmet needs in genitourinary cancers, including bladder, kidney and prostate cancer.