Merck Secures EU Approval for Keytruda Combo, First-of-Its-Kind Bladder Cancer Treatment

The European Commission approved Merck’s anti-PD-1 therapy, Keytruda, in combination with Padcev.

The regimen treats adult patients with resectable muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy.

This marks the first PD-1 inhibitor plus antibody-drug conjugate combination approved for this specific patient group in the European Union.

Approval followed results from the pivotal Phase 3 KEYNOTE-905 trial.

Study data demonstrated statistically significant and clinically meaningful improvements in both event-free survival and overall survival.