FDA Grants Accelerated Approval for Elrexfio (elranatamab-bcmm) for Relapsed or Refractory Multiple Myeloma
Pfizer Inc. announced the U.S. Food and Drug Administration (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.
• The approval of Elrexfio (elranatamab-bcmm) is based on clinically meaningful response rates and duration of response from Phase 2 MagnetisMM-3 study.
• Elrexfio is the first off-the-shelf (ready-to-use) fixed-dose subcutaneous BCMA-directed agent in the U.S. with the option for every-other-week long-term dosing after 24 weeks of weekly treatment.
• Pfizer continues to advance the MagnetisMM clinical program to expand Elrexfio into earlier lines of treatment, both as monotherapy and in combination with standard or novel therapies.
Used to treat multiple myeloma (MM), which is a type of blood cancer that affects plasma cells made in the bone marrow, Elrexfio is a B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody (BsAb). Elrexfio binds to the B-cell maturation antigen surface (BCMA) of multiple myeloma cells and binds to the CD3 receptor on the T-cells.
