What's Happening?
Merck has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of KEYTRUDA (pembrolizumab) in combination with Padcev (enfortumab vedotin-ejfv) for adults
with resectable muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy. This recommendation is based on the results from the Phase 3 KEYNOTE-905 trial, which demonstrated significant improvements in event-free survival, overall survival, and pathologic complete response rates compared to surgery alone. The combination therapy reduced the risk of event-free survival events by 60% and the risk of death by 50%. The European Commission will review this recommendation for marketing authorization in the EU, Iceland, Liechtenstein, and Norway, with a decision expected by the third quarter of 2026.
Why It's Important?
This development is significant as it offers a new treatment option for patients with muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy, a group that currently faces limited treatment options. The positive results from the KEYNOTE-905 trial suggest that the combination of KEYTRUDA and Padcev could significantly improve survival outcomes for these patients. If approved, this would be the first PD-1 inhibitor plus antibody-drug conjugate regimen available for this patient population in the European Union, potentially setting a new standard of care and addressing a significant unmet medical need.
What's Next?
Following the positive opinion from the CHMP, the European Commission will review the recommendation for marketing authorization. A final decision is expected by the third quarter of 2026. If approved, this combination therapy could become a new standard treatment for MIBC patients ineligible for cisplatin-based chemotherapy. The approval process in the EU will be closely watched by stakeholders, including healthcare providers and patients, as it could influence treatment protocols and availability in other regions.
