Global pharma powerhouse Merck has secured European Union approval for its blockbuster immunotherapy KEYTRUDA in combination with Padcev.

 

This marks a major advance for patients with resectable muscle-invasive bladder cancer (MIBC) who cannot receive cisplatin-based chemotherapy.

 

The decision makes the KEYTRUDA-Padcev combination the first and only PD-1 inhibitor plus antibody-drug conjugate (ADC) regimen approved in the EU for these patients. The treatment will be used before surgery and continued afterward as adjuvant therapy following radical cystectomy.

 

The approval is based on results from the pivotal Phase 3 KEYNOTE-905 trial, also known as EV-303, conducted in partnership with Pfizer and Astellas. The study showed the combination significantly outperformed surgery alone, delivering substantial gains in event-free survival, overall survival and pathologic complete response rates.

 

Patients receiving KEYTRUDA plus Padcev saw a 60% reduction in the risk of disease progression, recurrence or death compared with surgery alone. The regimen also cut the risk of death by 50%. More than half of treated patients achieved a pathologic complete response, compared with fewer than 9% of patients who underwent surgery alone.

 

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.

 

“Patients with resectable muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy face an aggressive disease and few effective therapies, with surgery alone as the longstanding standard of care,” said Professor Christof Vulsteke, head of Integrated Cancer Center Ghent (IKG) and Clinical Trial Unit Oncology Ghent and KEYNOTE-905 principal investigator. 

 

“Based on robust data from the KEYNOTE-905 trial, this approval marks a turning point in bladder cancer care. It introduces a potentially practice-changing perioperative treatment option that may significantly improve outcomes and extend survival for this underserved patient population across the European Union.”

 

Merck executives hailed the approval as a long-awaited breakthrough in a treatment setting that has seen limited innovation.

 

“For patients with resectable muscle-invasive bladder cancer in Europe, this approval represents a meaningful advance after years of limited progress in the field,” said Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. 

 

“As the first PD-1 inhibitor plus antibody-drug conjugate regimen approved in this setting, this treatment is poised to address a crucial unmet need, reflecting our continued commitment to delivering innovative KEYTRUDA-based therapies to patients with bladder cancer worldwide.”

 

The approval authorizes marketing of the regimen across all 27 European Union member states, as well as Iceland, Liechtenstein and Norway. Commercial launches will occur country by country as reimbursement processes are completed.

 

With the latest approval, Merck strengthens KEYTRUDA's position in bladder cancer and expands access to a treatment that could reshape care for patients with few therapeutic options and historically poor outcomes.