User:Noxoug1/elranatamab

elranatamab, sold under the brand name Elrexfio, is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma.

The primary mechanism of action of elranatamab is designed to bind to BCMA, which is highly expressed on the surface of multiple myeloma cells, and CD3 receptors found on the surface of T-cells, bridging them together and activating the T-cells to kill the myeloma cells. Elranatamab is administered subcutaneously.

Elranatamab was approved for medical use in the United States in August 2023.

Medical uses
elranatamab is indicated for the treatment of adults 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.

Elranatamab is an investigational, off-the-shelf, humanized BCMA CD3-targeted BsAb. The binding affinity of elranatamab for BCMA and CD3 has been engineered to elicit potent T-cell-mediated anti-myeloma activity.

Adverse effects
The most common adverse reactions include cytokine release syndrome (CRS), fatigue, injection site reaction, diarrhea, upper respiratory tract infection, musculoskeletal pain, pneumonia, decreased appetite, rash, cough, nausea, and pyrexia.

History
The safety and effectiveness of elranatamab was evaluated in MagnetisMM-3 (NCT04649359), an open-label, single-arm, multi-center study that included patients with relapsed/refractory MM who are refractory to at least one proteasome inhibitor, one immunomodulatory drug, and one anti-CD38 antibody.

Overall, the study consisted of 97 participants naïve to prior BCMA-directed therapy and who had previously received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

The FDA granted approval of Elrexfio to Pfizer Inc.