Bristol-Myers Squibb Company has announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) as a single agent for the treatment of previously untreated patients, specifically those with BRAF V600 mutation positive unresectable or metastatic melanoma.
As part of the Complete Response Letter, the FDA indicated the need for additional data in the BRAF mutated patient population. Bristol-Myers Squibb is working to evaluate the request outlined by the FDA and will continue to work closely with the agency to determine whether additional data, currently under review, adequately addresses these comments.
The sBLA submitted for Opdivo as a single agent for previously untreated metastatic melanoma was based on clinical data from the Phase 3 CheckMate -066 trial which evaluated Opdivo in treatment-naïve patients with BRAF wild-type advanced melanoma compared to dacarbazine. The FDA approved Opdivo as a single agent for the treatment of patients with BRAF wild-type unresectable or metastatic melanoma, based on CheckMate -066, on November 23, 2015. In addition to data from CheckMate -066, the Company submitted data for Opdivo in BRAF V600 mutation positive metastatic melanoma, which was the subject of the FDA’s Complete Response Letter.
A separate sBLA, which included data from CheckMate -067 evaluating Opdivo as a single agent and in combination withYervoy (ipilimumab) in patients with previously untreated advanced melanoma, was accepted by the FDA for review in September and granted Priority Review with a target action date of January 23, 2016. Data for Opdivo monotherapy in bothBRAF wild-type and BRAF V600 mutation positive advanced melanoma was included as part of this application.