Jan 15, 2020: Bristol-Myers Squibb Company announced the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) with Yervoy (ipilimumab) for the first-line treatment of patients with the metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.
The FDA has granted the application Priority Review with the Prescription Drug User Fee Act (PDUFA) aim date of May 15, 2020.This application is based on data from Part 1 of the Phase 3 CheckMate -227 trial evaluating Opdivo plus Yervoy vs. chemotherapy in patients with previously untreated NSCLC, in which the double immunotherapy combination demonstrated significant improvement in overall survival vs. chemotherapy alone. The safety profile of the Opdivo plus Yervoy was consistent with previously reported studies and no new safety signals were observed.
CheckMate -227 is a multi-part open-label Phase 3 trial that evaluates Opdivo-based regimens vs. platinum-doublet chemotherapy in patients with the first-line advanced non-small cell lung cancer across non-squamous and squamous tumor histologies. https://news.bms.com/press-release/corporatefinancial-news/us-food-and-drug-administration-accepts-priority-review-bris-1