Bristol Myers Squibb has announced that the European Medicines Agency (EMA) has accepted an extension application for a new subcutaneous Opdivo (nivolumab) formulation. This formulation includes a new solution for injection and a strength of 600 mg/vial.
The application seeks approval for the subcutaneous use of Opdivo to treat multiple solid tumors in adults. This includes monotherapy, maintenance therapy following nivolumab and ipilimumab combination therapy, and in combination with chemotherapy or cabozantinib.
The EMA’s acceptance of the application initiates its centralized review process, confirming the completeness of the submission.
Results from the Phase 3 CheckMate -67T trial showed that subcutaneous nivolumab demonstrated noninferiority to intravenous Opdivo regarding time-averaged serum concentration and trough serum concentration at steady state. Additionally, the objective response rate was also non-inferior.
The safety profile of subcutaneous nivolumab was consistent with the intravenous formulation.
The submission builds on Bristol Myers Squibb’s commitment to developing innovative formulations to improve patient experiences. The company aims to reduce administration time and increase convenience for patients receiving Opdivo treatment.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
