Posted by Michael Wonder on 28 May 2025
Bristol Myers Squibb receives European Commission approval for the subcutaneous formulation of Opdivo (nivolumab) across multiple solid tumour indications
28 May 2025 - Approval is based on results from the Phase 3 CheckMate -67T clinical trial which demonstrated non-inferiority in the co-primary endpoints of Cavgd28 and Cminss, and consistent efficacy in the secondary endpoint of overall response rate, for the subcutaneous formulation of Opdivo vs. its intravenous formulation.
Bristol Myers Squibb today announced that the European Commission has approved a new Opdivo (nivolumab) formulation associated with a new route of administration (subcutaneous use), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial).
