Merck and Co Inc (MRK)

[DewDiligence]

FDA approves Keytruda monotherapy for second-line NMIBC, regardless of PD-L1 status:

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-bcg-unresponsive-high-risk-non-muscle-invasive-bladder-cancer

This accelerated approval is based on the single-arm KEYNOTE-057 study. ODAC backed approval by a 9-4 vote (#msg-152848797).