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Opdivo gets Priority Review for third-line SCLC

April 18, 2018 10:51 PM UTC

Bristol-Myers Squibb Co. (NYSE:BMY) said FDA accepted and granted Priority Review to an sBLA for Opdivo nivolumab to treat small cell lung cancer in patients whose disease has progressed after two or more prior therapies. The PDUFA date is Aug. 16.

The sBLA was based on data from the SCLC cohort of the Phase I/II CheckMate -032 trial in which Opdivo as monotherapy led to an overall response rate (ORR) of 10%, a median overall survival (OS) of 4.4 months and a one-year OS rate of 33% in 98 previously treated patients (see BioCentury Extra, June 6, 2016)...