FDA Grants Accelerated Approval to Linvoseltamab-gcpt for Relapsed or Refractory Multiple Myeloma

On July 2, the FDA granted accelerated approval to linvoseltamab-gcpt, a bispecific B-cell maturation antigen-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

For more information, read the FDA announcement and the Regeneron Pharmaceuticals press release.

Posted on 7/2/2025