2 July 2025 - Today the FDA granted accelerated approval to linvoseltamab-gcpt (Lynozyfic, Regeneron Pharmaceuticals), a bispecific B-cell maturation antigen 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, an immunomodulatory agent and an anti-CD38 monoclonal antibody.

Efficacy was evaluated in LINKER-MM1, an open-label, multi-centre multi-cohort trial.

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