FDA approves Merck’s Keytruda and Padcev for bladder cancer treatment
MRK•FDA clears perioperative use in muscle-invasive bladder cancer
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.
