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DewDiligence

12/02/19 3:21 PM

#227258 RE: DewDiligence #220250

Keytruda PDUFA date in NMIBC is Jan 2020 (with priority review):

https://finance.yahoo.com/news/fda-grants-priority-review-merck-114500643.html

The filing was based on data from KEYNOTE-057 (NCT02625961), a Phase 2, multicenter, open-label, single-arm trial in 102 patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in-situ (CIS) with or without papillary tumors who were ineligible for or had elected not to undergo cystectomy (Cohort A).