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ARTICLE | Clinical News

Opdivo gets accelerated approval in SCLC population

August 31, 2018 6:42 PM UTC

FDA granted accelerated approval to Opdivo nivolumab from Bristol-Myers Squibb Co. (NYSE:BMY) to treat small cell lung cancer in a third-line setting. BMS said the approval is the first for an immuno-oncology therapy in the indication, which includes SCLC patients whose cancer has progressed after platinum-based chemotherapy and at least one other line of treatment.

FDA reviewed the anti-PD-1 mAb based on data from a cohort of the Phase I/II CheckMate -032 trial, in which Opdivo led to a 12% overall response rate (ORR) among 109 patients and a median duration of response of 17.9 months among 13 responders. Opdivo had received Priority Review in the indication...