Keytruda Approved for Non-Muscle Invasive Bladder Cancer

The FDA approved Merck’s Keytruda (pembrolizumab) to treat adults with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC).

The approval was based on results from a phase 2 clinical trial which showed a complete response rate in the 96 patients of 41 percent, with a median response duration of 16.2 months. 

The FDA’s Oncologic Drugs Advisory Committee voted 9-4 to recommend approval of pembrolizumab for the indication.