Regeneron Pharmaceuticals (REGN) said Friday that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended a conditional marketing authorization for linvoseltamab to treat adults with relapsed and refractory multiple myeloma.
The company said the recommendation specifically covers patients who have received at least three prior therapies.
The committee's positive opinion was based on data from a phase 1/2 trial investigating linvoseltamab in 282 patients, Regeneron said.
The European Commission is expected to issue a final decision in the coming months, the company said.
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