FDA accepts filing of Opdivo + Yervoy combination to treat first-line metastatic or recurrent NSCLC with no EGFR or ALK genomic tumor aberrations.- BMS

Bristol-Myers Squibb Company announced the FDA has accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of patients with 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 a Prescription Drug User Fee Act (PDUFA) goal date of May 15, 2020. This application is based on data from Part 1 of the Phase III CheckMate -227 trial evaluating Opdivo plus Yervoy versus chemotherapy in patients with previously untreated NSCLC, in which the dual immunotherapy combination demonstrated significant improvement in overall survival versus chemotherapy alone. The safety profile of Opdivo plus Yervoy was consistent with previously reported studies and no new safety signals were observed.