Posted by Michael Wonder on 18 Apr 2018
U.S. FDA accepts supplemental biologics license application for Opdivo (nivolumab) in previously treated patients with small cell lung cancer and grants priority review
18 April 2018 - Bristol-Myers Squibb today announced that the U.S. FDA has accepted for priority review its supplemental biologics license application for Opdivo (nivolumab) to treat patients with small cell lung cancer whose disease has progressed after two or more prior lines of therapy.
The FDA action date is 16 August 2018.
The submission was based on safety and efficacy data from the small cell lung cancer cohort of the Phase 1/2 CheckMate-032 trial evaluating Opdivo monotherapy following platinum-based chemotherapy.
