Bristol Myers announces updated action date by FDA for nivolumab

Bristol Myers announced that the FDA has reassigned the previously announced Prescription Drug User Fee Act goal date of the Biologics License Application for the subcutaneous formulation of Opdivo – nivolumab – co-formulated with Halozyme’s proprietary recombinant human hyaluronidase across all previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy – ipilimumab – combination therapy, or in combination with chemotherapy or cabozantinib. The updated goal date is December 29. The application is based on results from CheckMate -67T, the first Phase 3 trial of the subcutaneous formulation of nivolumab to evaluate and demonstrate noninferior pharmacokinetics, efficacy and consistent safety vs. its intravenous formulation. If approved, subcutaneous nivolumab has the potential to be the first and only subcutaneously administered PD-1 inhibitor.