Posted by Michael Wonder on 14 Aug 2023
FDA grants accelerated approval to elranatamab-bcmm for multiple myeloma
14 August 2023 - Today, the FDA granted accelerated approval to elranatamab-bcmm (Elrexfio, Pfizer), 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 MagnetisMM-3, an open-label, single-arm, multi-centre study that included patients with relapsed/refractory multiple myeloma who are refractory to at least one proteasome inhibitor, one immunomodulatory drug, and one anti-CD38 antibody.
