FDA Grants Accelerated Approval to Lynozyfic for Relapsed or Refractory Multiple Myeloma

The FDA granted accelerated approval to linvoseltamab-gcpt (Lynozyfic, Regeneron), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD) and an anti-CD38 monoclonal antibody.

Efficacy was evaluated in LINKER-MM1 (ClinicalTrials.gov Identifier: NCT03761108), an open-label, multicenter