The FDA granted accelerated approval to elranatamab-bcmm for treatment of certain patients with multiple myeloma.
The approval applies to use of the agent by adults with relapsed or refractory disease who received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
Elranatamab-bcmm (Elrexfio, Pfizer) is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager.
The FDA based the approval in part on results of the phase 2, single-arm study.
The primary efficacy population included 97 patients with
