By Colin Kellaher
Bristol Myers Squibb said a key European regulatory committee is backing a formulation of its blockbuster cancer drug Opdivo that can be injected under the skin.
Bristol Myers on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of a subcutaneous formulation of Opdivo across multiple previously approved adult solid tumors as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy combination therapy, or in combination with chemotherapy or cabozantinib.
The Princeton, N.J., biopharmaceutical company said the European Commission, which generally follows CHMP's advice, will now review the recommendation, with a decision expected by June 2.
Opdivo, which harnesses the body's own immune system to fight cancer and generated more than $9.3 billion in revenue last year, is currently administered intravenously in Europe.
The U.S. Food and Drug Administration approved the subcutaneous formulation of Opdivo late last year.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
March 28, 2025 08:34 ET (12:34 GMT)
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