FDA issues complete response letter to sBLA for Opdivo (nivolumab) in untreated metastatic melanoma- BMS

The FDA has issued a Complete Response Letter for its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab), from BMS, 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 III 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.