10:20 AM EDT, 05/28/2025 (MT Newswires) -- (Updates with mention of Halozyme Therapeutics ( HALO ) in the first paragraph and headline.)

Bristol Myers Squibb ( BMY ) and Halozyme Therapeutics ( HALO ) said Wednesday the European Commission approved a subcutaneous formulation of Opdivo for treating multiple adult solid tumors.

The decision makes Opdivo the first PD-1 inhibitor cleared for subcutaneous use in the EU, the companies said.

Bristol Myers said approval was based on phase 3 data showing noninferior pharmacokinetics and comparable efficacy and safety versus the intravenous formulation.

CheckMate-67T data showed a 24% response rate for subcutaneous Opdivo versus 18% for IV Opdivo, with consistent safety profiles, Bristol Myers added.

The approval applies across the EU, Iceland, Liechtenstein, and Norway, and follows US clearance of Opdivo Qvantig in December 2024, the companies said.

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