Regeneron announces U.S. FDA accepted priority review for BLA for linvoseltamab

Regeneron Pharmaceuticals announced that the U.S. Food and Drug Administration, FDA, has accepted for Priority Review the Biologics License Application, BLA, for linvoseltamab to treat adult patients with relapsed/refractory, R/R, multiple myeloma, MM, that has progressed after at least three prior therapies. The target action date for the FDA decision is August 22, 2024. Linvoseltamab is an investigational bispecific antibody designed to bridge B-cell maturation antigen on multiple myeloma cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing. The BLA is supported by data from a Phase 1/2 trial investigating linvoseltamab in R/R MM, which were last shared in December 2023. Earlier this month, the European Medicines Agency accepted for review the Marketing Authorization Application for linvoseltamab in the same indication.