The U.S. Food and Drug Administration (FDA) has reassigned the previously announced Prescription Drug User Fee Act (PDUFA) goal date of the Biologics License Application (BLA) for the subcutaneous formulation of nivolumab (Opdivo, BMS) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20) to Dec 29, 2024.
The original PDUFA date was February 28, 2025.
The BLA is seeking approval of subcutaneous nivolumab across all previously approved adult, solid tumor nivolumab indications as monotherapy, monotherapy maintenance following completion of nivolumab plus ipilimumab (Yervoy, BMS) combination therapy, or in combination with chemotherapy or cabozantinib.
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.
