FDA requests more data for Opdivo in treating BRAF V600 mutation-positive melanoma

Source: healio.com/dermatology, December 2015

Bristol-Myers Squibb announced that the FDA has requested additional data in its response to its supplemental biologics license application for Opdivo as monotherapy for previously untreated patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.

The FDA issued a complete response letter for the supplemetal biologics license application to Bristol-Myers Squibb (BMS) indicating the need for additional data in the patient population with the BRAF mutation, according to a press release. BMS reported it is evaluating the agency’s request and will work closely with the FDA “to determine whether additional data, currently under review, adequately addresses these comments.”

BMS included clinical data from the phase 3 CheckMate -066 trial, which studied Opdivo (nivolumab) in comparison to dacarbazine in treatment-naïve patients with BRAF wild-type advanced melanoma, according to the release.