FDA approves Merck’s Keytruda and Padcev for bladder cancer treatment

The U.S. Food and Drug Administration approved Keytruda, including Keytruda QLEX, in combination with Padcev for the perioperative treatment of adults with muscle-invasive bladder cancer, regardless of cisplatin eligibility.

The approval was supported by Phase 3 KEYNOTE-B15 results in cisplatin-eligible patients, which showed an event-free survival hazard ratio of 0.53 and an overall survival hazard ratio of 0.65.

The trial enrolled 808 patients, and Merck said the regimen is the first PD-1 inhibitor plus an antibody-drug conjugate cleared in this setting.