August 16, 2023 – Pfizer announced that the FDA has granted accelerated approval to ELREXFIO™ (elranatamab-bcmm) for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Approval was based on the results of the single-arm Phase 2 MagnetisMM-3 trial, and continued approval for this indication is contingent upon verification of clinical benefit in a confirmatory trial(s).
ELREXFIO is a subcutaneously delivered B-cell maturation antigen (BCMA)-CD3-directed bispecific antibody (BsAb) immunotherapy that binds to BCMA on myeloma cells and CD3 on T-cells, bringing them together and activating the T-cells to kill myeloma cells.
For patients who are prescribed ELREXFIO, Pfizer offers the support of Patient Access Navigators, through our Pfizer Oncology Together program, who provide personalized services for all aspects of treatment, including financial assistance resources, treatment support, and resources to navigate potential insurance and coverage issues.