EU Approves KEYTRUDA-Padcev for Bladder Cancer
Merck has secured European Union approval for a new perioperative treatment regimen combining KEYTRUDA (pembrolizumab) and Padcev (enfortumab vedotin-ejfv) for adults with resectable muscle-invasive bladder cancer (MIBC) who are unable to receive cisplatin-based chemotherapy. The approval marks a significant advance for patients with limited treatment options and introduces the first and only combination of a PD-1 inhibitor and an antibody-drug conjugate approved for this patient population in the European Union.
The decision is based on positive findings from the pivotal Phase 3 KEYNOTE-905 trial, also known as EV-303, which was conducted in collaboration with Pfizer and Astellas. The study evaluated the combination as neoadjuvant therapy before surgery, followed by continued treatment after radical cystectomy as adjuvant therapy.
According to the trial results, patients receiving the combination therapy experienced substantial improvements compared with those undergoing surgery alone. The treatment reduced the risk of disease recurrence, progression, or death by 60%, while also cutting the risk of death by 50%. In addition, more than half of treated patients achieved a pathological complete response, meaning no detectable cancer remained in tissue removed during surgery. The pathological complete response rate reached 57.1%, compared with 8.6% among patients treated with surgery alone.
Researchers also reported that the median event-free survival and overall survival had not yet been reached for patients receiving the combination, indicating sustained benefits during the study period. These findings suggest the regimen could significantly improve long-term outcomes for patients who are not eligible for cisplatin, a group that has historically faced poor prognoses and limited therapeutic alternatives.
Professor Christof Vulsteke, Head of the Integrated Cancer Center Ghent and principal investigator of the KEYNOTE-905 study, described the approval as an important milestone for bladder cancer treatment in Europe. He noted that surgery alone has long remained the standard of care for cisplatin-ineligible patients despite the aggressive nature of muscle-invasive bladder cancer. Based on the strong clinical evidence generated by the trial, he said the newly approved perioperative regimen has the potential to change clinical practice by improving survival and reducing the likelihood of disease recurrence.
Dr. Marjorie Green, Senior Vice President and Head of Oncology Global Clinical Development at Merck Research Laboratories, said the approval represents meaningful progress after years of limited innovation for patients with muscle-invasive bladder cancer. She emphasized that the combination is the first PD-1 inhibitor plus antibody-drug conjugate regimen approved in this treatment setting and reflects Merck’s continued commitment to expanding KEYTRUDA-based therapies for patients with difficult-to-treat cancers worldwide.
The approval covers all 27 member states of the European Union, as well as Iceland, Liechtenstein, and Norway. However, commercial availability in individual countries will depend on the completion of national pricing and reimbursement processes.
The European Commission’s decision follows a positive opinion issued by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in May 2026. It also builds on earlier regulatory momentum, as the U.S. Food and Drug Administration approved KEYTRUDA and the subcutaneous formulation KEYTRUDA QLEX in combination with Padcev for the same indication in November 2025.
Muscle-invasive bladder cancer remains one of the most aggressive forms of bladder cancer, and many patients are unable to receive cisplatin because of underlying medical conditions. The approval of the KEYTRUDA-Padcev combination provides a new treatment option designed to improve outcomes before and after surgery, offering hope for longer survival and better disease control in a patient population with significant unmet medical needs.