US approval has been granted to Keytruda as a monotherapy for treating patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC).
This is the third label indication for Merck’s Keytruda in bladder cancer. It is now the first anti-PD-1 therapy approved for certain patients with high-risk non-muscle invasive bladder cancer.
The approval was based on data from KEYNOTE-057 (NCT02625961), a multi-centre, open-label, single-arm trial in 96 patients.
“As the first anti-PD-1 therapy approved in this setting, Keytruda will be a new clinical option for a patient population that previously had limited FDA-approved therapies available,” said Scot Ebbinghaus, Vice President of Clinical Research at Merck Research Laboratories.