Ketyruda Supplemental BLA Gets Priority Review for Bladder Cancer

Merck received priority review for a supplemental biologics license application for Keytruda (pembrolizumab) for treatment of certain patients with high-risk, non-muscle invasive bladder cancer (NMIBC).

Currently approved for multiple forms of cancer, Keytruda is an anti-PD-1 protein therapy that works by increasing the ability of the body’s immune system to fight tumor cells. The application seeks approval for treatment of NMIBC patients who are unresponsive to the Bacillus Calmette-Guerin (BCG) vaccine.

The FDA Oncologic Drugs Advisory Committee will consider the supplemental BLA on Tuesday, Dec. 17. The agency is expected to make a decision on the application in January.