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).