Linvoseltamab BLA accepted for priority review

The US Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) submitted by US biotech Regeneron Pharmaceuticals (Nasdaq: REGN) for linvoseltamab to treat adult patients with relapsed/refractory (R/R) multiple myeloma (MM) that has  progressed after at least three prior therapies.

Regeneron noted that 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 I/II pivotal trial (LINKER-MM1) investigating linvoseltamab in R/R MM, which were last shared in December 2023.