The European Commission has approved Merck’s Keytruda in combination with Padcev as a perioperative treatment for adults with resectable muscle-invasive bladder cancer, opening a new treatment option regardless of patients’ eligibility for cisplatin-based chemotherapy.

 

The approval covers treatment before surgery, followed by continued treatment after radical cystectomy, and is based on results from the Phase 3 KEYNOTE-B15 trial, also known as EV-304.

 

The combination demonstrated a 47% reduction in the risk of disease progression, recurrence or death and a 35% reduction in the risk of death compared with neoadjuvant chemotherapy and surgery among patients eligible for cisplatin-based chemotherapy.

 

The findings could expand treatment options for patients facing a cancer in which recurrence remains a major challenge despite established treatment approaches.

 

“Although cisplatin-based chemotherapy has been a standard treatment approach for many patients with muscle-invasive bladder cancer, recurrence remains a significant challenge,” said Alfonso Gómez de Liaño, Hospital Universitario Insular de Gran Canaria, and KEYNOTE-B15 primary investigator. 

 

“Based on results from the KEYNOTE-B15 trial, today’s approval is a meaningful advance for patients with muscle-invasive bladder cancer in the European Union, extending this chemotherapy-free perioperative treatment option to patients regardless of cisplatin eligibility.”

 

The Phase 3 KEYNOTE-B15 trial enrolled 808 patients with previously untreated MIBC who were eligible for cisplatin-based chemotherapy. Participants received either Keytruda plus Padcev before and after surgery or standard neoadjuvant chemotherapy with gemcitabine and cisplatin followed by surgery.

 

The combination significantly improved event-free survival, reducing the risk of events—including disease progression, recurrence or death—by 47% compared with chemotherapy and surgery.

 

The regimen also reduced the risk of death by 35%, demonstrating a statistically significant improvement in overall survival.

 

The trial reported a pathologic complete response rate of 55.8% with Keytruda plus Padcev, compared with 32.5% with neoadjuvant chemotherapy. This means a substantially higher proportion of patients had no detectable residual cancer in the tissue examined after surgery.

 

The European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive recommendation for the treatment in September 2026, paving the way for the European Commission’s approval.

 

The approval is significant because cisplatin-based chemotherapy remains a standard preoperative treatment for eligible patients, while a substantial proportion of people with MIBC cannot receive cisplatin and may have more limited treatment options.

 

The newly approved regimen offers a chemotherapy-free perioperative approach and is authorised for use across all 27 EU member states, as well as Iceland, Liechtenstein and Norway.

 

However, the timing of commercial availability will vary by country, depending on factors including national reimbursement procedures.

 

“Building on the previous approval of KEYTRUDA plus Padcev in the European Union less than six months ago, we’re pleased to bring this important treatment option to a broader patient population as the first PD-1 inhibitor plus antibody-drug conjugate regimen approved for people with muscle-invasive bladder cancer regardless of cisplatin eligibility,” said Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. 

 

"This approval represents encouraging progress in bladder cancer care and underscores our commitment to addressing the needs of people who are living with this disease.”