Bristol-Myers Squibb Gains European Commission Approval for Subcutaneous Opdivo® in Treating Multiple Solid Tumors

Reuters
05-28
Bristol-Myers Squibb Gains European Commission Approval for Subcutaneous Opdivo® in Treating Multiple Solid Tumors

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.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Bristol-Myers Squibb Company published the original content used to generate this news brief via Business Wire (Ref. ID: 20250527346996) on May 28, 2025, and is solely responsible for the information contained therein.

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