Elrexfio FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 15, 2023.
FDA Approved: Yes (First approved August 14, 2023)
Brand name: Elrexfio
Generic name: elranatamab-bcmm
Dosage form: Injection
Company: Pfizer Inc.
Treatment for: Multiple Myeloma
Elrexfio (elranatamab-bcmm) is a B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody (BsAb) for the treatment of patients with relapsed or refractory multiple myeloma.
- Elrexfio is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).
- Multiple myeloma is a type of blood cancer that affects plasma cells made in the bone marrow.
- Elrexfio contains elranatamab-bcmm, a bispecific antibody designed to bind to BCMA which is highly expressed on the surface of multiple myeloma cells, and the CD3 receptor found on the surface of cancer-fighting T-cells, bridging them together to activate an immune response. Elrexfio works in the treatment of multiple myeloma by activating the T-cells to kill the myeloma cells.
- Elrexfio is administered subcutaneously weekly or biweekly after an initial step-up dosing phase. Subcutaneous administration offers more convenience over treatments administered by intravenous administration, and may mitigate the risk of potential adverse events, such as cytokine release syndrome (CRS).
- The product label for Elrexfio carries a Boxed Warning for Cytokine Release Syndrome (CRS) and neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS). Elrexfio is available only through a restricted program called the Elrexfio Risk Evaluation and Mitigation Strategy (REMS).
- Warnings and precautions associated with Elrexfio include infections (which can be severe, life-threatening, or fatal), neutropenia, hepatotoxicity, and fetal harm.
- Common adverse reactions include CRS, fatigue, injection site reaction, diarrhea, upper respiratory tract infection, musculoskeletal pain, pneumonia, decreased appetite, rash, cough, nausea, and pyrexia. Common laboratory abnormalities include decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased white blood cells, and decreased platelets.
Development timeline for Elrexfio
Further information
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