By Colin Kellaher
Regeneron Pharmaceuticals said the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended conditional marketing approval of linvoseltamab for certain adults with the blood cancer multiple myeloma.
Regeneron on Friday said the recommendation covers adults with adults with relapsed and refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and have shown disease progression on the last therapy.
The Tarrytown, N.Y., biotechnology company said the European Commission, which generally follows the CHMP's advice, is expected to announce a final decision in the coming months.
The U.S. Food and Drug Administration earlier this month accepted Regeneron's resubmitted application seeking approval of linvoseltamab and set a target action date of July 10 for a decision.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
February 28, 2025 07:34 ET (12:34 GMT)
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