According to a press release from Regeneron, the U.S. 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 pivotal trial (LINKER-MM1) investigating linvoseltamab in RRMM, which were last shared in December 2023." Read the full press release to learn more.