Bristol Myers Gets Positive CHMP Opinion for Earlier Abecma Use

By Colin Kellaher

Bristol Myers Squibb on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of earlier use of the Abecma gene therapy it is developing with 2seventy bio.

The New York biopharmaceutical company said the recommendation covers use of Abecma earlier in the treatment course for people with the blood cancer multiple myeloma.

The European Commission, which generally follows CHMP's advice, will now review the recommendation.

Bristol Myers said a green light would make Abecma the first chimeric antigen receptor T-cell, or CAR-T, cell therapy available in the European Union for patients with triple-class exposed relapsed and refractory multiple myeloma earlier in their treatment.

Bristol Myers and 2seventy, a Cambridge, Mass., biotechnology company, are jointly developing and commercializing Abecma in the U.S., with Bristol responsible for manufacturing and commercialization outside of the U.S.

The companies in November said the U.S. Food and Drug Administration is planning to hold an advisory committee meeting on a similar earlier approval for Abecma, pushing the agency's review beyond its Dec. 16 target action date.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

January 26, 2024 07:44 ET (12:44 GMT)

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