EU Regulators Back KEYTRUDA + Padcev Bladder Cancer Combination
Merck's KEYTRUDA and Padcev combination has taken another step towards EU approval, after a European medicines committee issued a positive opinion. The treatment is for adults with resectable muscle-invasive bladder cancer who cannot receive cisplatin-based chemotherapy. If approved, it would be the first PD-1 inhibitor plus antibody-drug conjugate combination available in the EU for this type of bladder cancer.
The decision was based on Phase 3 KEYNOTE-905 trial results, which showed that the Keytruda + Padcev regimen significantly improved outcomes compared to surgery alone. The combination reduced the risk of cancer progression or recurrence by about 60% and cut the risk of death by around 50%. More patients on the combo showed no detectable cancer after treatment compared to surgery alone (57% vs 9%).