Drugs and FDA
FDA grants accelerated approval to elranatamab for multiple myeloma
Elranatamab is approved for adults with relapsed or refractory multiple myeloma after at least four prior lines of therapy.
The FDA granted accelerated approval to elranatamab-bcmm (Elrexfio) on August 14, 2023, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. Those treatments must include a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
The approval was based on the MagnetisMM-3 study. Among 97 patients who had not received prior BCMA-directed therapy, the objective response rate was 57.7%. Median duration of response was not reached after a median follow-up of 11.1 months among responders.
The FDA’s prescribing information carries a boxed warning for life-threatening or fatal cytokine release syndrome and neurologic toxicity. The drug is available only through the ELREXFIO Risk Evaluation and Mitigation Strategy program.
