Bristol Myers Squibb has received approval from the European Commission for the subcutaneous formulation of Opdivo® (nivolumab) for use across multiple solid tumor indications. This makes Opdivo the first and only PD-1 inhibitor approved for subcutaneous administration in the EU. The approval follows results from the Phase 3 CheckMate -67T clinical trial, which demonstrated the noninferiority of the subcutaneous version compared to its intravenous counterpart. The decision is applicable in all 27 EU member states, as well as Iceland, Liechtenstein, and Norway. This new formulation offers a quicker, 3- to 5-minute injection, enhancing the patient experience while maintaining consistent efficacy and safety.
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