FDA Extends Action Date for sBLA Application for Opdivo in Previously Untreated Advanced Melanoma

Bristol-Myers Squibb Company (BMS) has announced that FDA has extended the action date for the supplemental Biologics License Application (sBLA) for Opdivo for the treatment of patients with previously untreated advanced melanoma. The company has taken the opportunity to submit additional data from the Opdivo clinical trial program to ensure the broadest data set, irrespective of BRAF status, was available for review. This submission constitutes a major amendment that will require additional time for review and the new FDA action date is 27 November 2015.

The sBLA was accepted by the FDA for filing and received priority review designation on 29 April 2015, and included data from the Phase III CheckMate -066 trial which evaluated Opdivo in treatment naïve patients with BRAF wild-type advanced melanoma as compared to dacarbazine chemotherapy (DTIC). The company will continue to work closely with the agency to support the review of this sBLA for Opdivo.