Posted by Michael Wonder on 06 May 2024
US FDA accepts Bristol Myers Squibb’s application for subcutaneous nivolumab (nivolumab and hyaluronidase)
6 May 2024 - Application based on results from CheckMate-67T, the first Phase 3 trial of the subcutaneous formulation of nivolumab to evaluate and demonstrate non-inferior pharmacokinetics, efficacy and consistent safety versus its intravenous formulation.
BMS today announced that the US FDA has accepted the BLA for the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20) (herein referred to as “ subcutaneous nivolumab”) across all previously approved adult, solid tumour Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.
