LGND - Bristol Myers Updates Action Date for Subcutaneous Opdivo | Benzinga
Bristol Myers Squibb (NYSE: BMY) announced that the FDA will now decide on the biologics license application (BLA) for the subcutaneous formulation of Opdivo (nivolumab) on Dec 29, 2024.
The subcutaneous formulation of Opdivo is co-formulated with Halozyme's proprietary recombinant human hyaluronidase (rHuPH20). The BLA seeks approval of the same across all previously approved adult, solid tumor indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy combination therapy, or in combination with chemotherapy or cabozantinib.
The BLA was accepted earlier this month with a target action date of Feb 28, 2025.
The application is based on results from the phase III CheckMate -67T study evaluating subcutaneous administration of Opdivo co-formulated with rHuPH20 compared to intravenous Opdivo in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy.
Per BMY, this is the first phase III study of the subcutaneous formulation of nivolumab to evaluate and demonstrate non-inferior pharmacokinetics, efficacy and consistent safety vis-a-vis its intravenous formulation (IV). The subcutaneous formulation has the potential to be ...