Halozyme and Bristol Myers’ combination receives updated FDA action date

Halozyme Therapeutics (HALO) announced that Bristol Myers (BMY) was reassigned a Prescription Drug User Fee Act goal date from the FDA for their Biologics License Application for the subcutaneous formulation of Opdivo – nivolumab – co-formulated with Enhanze, Halozyme’s proprietary recombinant human hyaluronidase enzyme, rHuPH20, 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 with Enhanze 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.