The European Commission has authorised Keytruda (pembrolizumab) plus Padcev (enfortumab vedotin‑ejfv) as a neoadjuvant treatment for adults with resectable muscle‑invasive bladder cancer who are ineligible for cisplatin. KEYNOTE‑905/EV‑303 (n=595) showed a 60% reduction in EFS events (median EFS not reached vs 15.7 months), a ~50% lower risk of death and a 57.1% pathologic complete response rate versus 8.6% with surgery alone. The EC decision follows a CHMP recommendation from May 2026; national reimbursement will determine commercial availability.
EC Approves Keytruda Plus Padcev as Pre‑Surgery Treatment for Resectable Muscle‑Invasive Bladder Cancer
The authorisation applies to adults with resectable MIBC who cannot be treated with cisplatin-based chemotherapy. Credit: Antonio Marca / Shutterstock.com.(Antonio Marca / Shutterstock.com.)
The European Commission has authorised Merck & Co’s (MSD) immunotherapy Keytruda (pembrolizumab) in combination with Padcev (enfortumab vedotin‑ejfv) as a neoadjuvant (pre‑surgery) treatment for adults with resectable muscle‑invasive bladder cancer (MIBC) who are ineligible for cisplatin‑based chemotherapy.
Key Trial Evidence
The approval is based on results from the Phase III KEYNOTE‑905/EV‑303 study, conducted by MSD in collaboration with Pfizer and Astellas. The trial enrolled 595 patients and compared perioperative Keytruda plus Padcev against surgery alone. The combination produced statistically significant and clinically meaningful benefits across multiple endpoints.
Primary Outcomes
- Event‑Free Survival (EFS): The combination reduced the risk of EFS events by 60%; median EFS was not reached for the combination arm versus 15.7 months for surgery alone.
- Overall Survival (OS): Risk of death was reduced by approximately 50% with Keytruda plus Padcev compared with surgery alone.
- Pathologic Complete Response (pCR): pCR rate was 57.1% with the combination versus 8.6% for surgery alone.
Regulatory and Access Notes
The EC decision follows a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in May 2026. The authorisation covers all 27 EU member states and extends to Iceland, Liechtenstein and Norway. Commercial availability in each country will depend on completion of national reimbursement and pricing procedures.
Both Keytruda and Padcev received approval for a similar perioperative indication in the United States in November 2025. The KEYNOTE‑905/EV‑303 programme remains ongoing to evaluate additional perioperative combinations and sequencing strategies.
Industry Comment
Dr Marjorie Green, Senior Vice‑President of MSD Research Laboratories and Global Head of Oncology Clinical Development, said: "This approval represents a meaningful advance for people with resectable MIBC in Europe after years of limited progress. As the first PD‑1 inhibitor plus antibody‑drug conjugate regimen authorised in this setting, it addresses an important unmet need and underscores our commitment to developing Keytruda‑based options for bladder cancer patients worldwide."
Note: This summary reports trial outcomes and regulatory decisions. Individual treatment decisions should be made by clinicians in consultation with patients and informed by full prescribing information, local guidelines and reimbursement status.
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