Bristol-Myers Squibb announced the U.S. Food and Drug Administration (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.
“The FDA’s acceptance of our application for Opdivo plus Yervoy represents an important milestone for patients with lung cancer in the United States, where, despite recent treatment advances, lung cancer remains the cause of more than 150,000 deaths each year,” said Sabine Maier, M.D., development lead, thoracic cancers, Bristol-Myers Squibb. “Lung cancer is the third tumor type where the combination of Opdivo and Yervoy has demonstrated significant long-term overall survival benefit in a randomized Phase 3 trial, which further validates the immunologic rationale for dual Immuno-Oncology therapy.”
This application is based on data from Part 1 of the Phase 3 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.
Source: Company Press Release