Linvoseltamab BLA accepted for FDA review for the treatment of relapsed/refractory multiple myeloma

Regeneron Pharmaceuticals

11 February 2025 - FDA decision expected by 10 July 2025.

Regeneron Pharmaceuticals today announced that the US FDA has accepted for review the resubmission of the biologics license application for linvoseltamab for the treatment of adult patients with relapsed/refractory multiple myeloma who have received at least four prior lines of therapy or those who received three prior lines of therapy and are refractory to the last line of therapy.

Read Regeneron Pharmaceuticals press release

Michael Wonder

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Michael Wonder

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Cancer , Medicine , US , Dossier