FDA Grants Accelerated Approval for Elrexfio (elranatamab-bcmm) for Relapsed or Refractory Multiple Myeloma

On August 14, 2023, the U.S. Food and Drug Administration granted accelerated approval to Pfizer’s Elrexfio (elranatamab-bcmm), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma (R/R MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. As with all FDA accelerated approvals, continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Elrexfio is the first FDA-approved BCMA-directed therapy that can be dosed once every 2 weeks after an initial 24 weeks of weekly therapy.

Approval of Elrexfio was based on data from the open-label, single-arm, multicenter Phase 2 MagnetisMM- 3 trial. The trial included adults with R/R MM who had previously received and were refractory to at least one proteasome inhibitor, one immunomodulatory drug, and one anti-CD38 antibody. Patients in Cohort A of the study were naïve to BCMA-directed therapy, while those in Cohort B had received prior BCMA- directed therapy. Among the 97 patients in Cohort A who had received four or more prior lines of therapy, the overall response rate was 58% after a median follow-up of 11.1 months, the duration of response was not reached, and the median time to first response was 1.2 months. Among the 63 patients in Cohort B who received four or more prior lines of therapy, the ORR was 33% after a median follow-up of 10.2 months.

Read more…