The US Food and Drug Administration (FDA) has given accelerated approval to elranatamab-bcmm (Elrexfio) to treat adults with relapsed or refractory multiple myeloma. More specifically, it is approved for those who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Multiple myeloma is a rare blood cancer characterized by the expansion of malignant plasma cells in the bone marrow. Individuals with multiple myeloma develop significant osteolytic bone lesions and have immunodeficiency that compromise their longevity and quality of life.
The accelerated approval is largely based on the results of the Phase 2 MagnetisMM-3 trial, and continued approval will be dependent on verification of clinical benefit in confirmatory trials.
In the Phase 2 trial, patients in cohort A of the trial received four or more lines of therapy prior to elranatamab (n=97) had an overall response rate was 58%, with an estimated 82% maintaining the response for at least nine months. The median time to first response was 1.2 months. In addition, patients in cohort B of the trial received four or more lines of therapy, including a B-cell maturation antigen (BCMA)-directed therapy, prior to elranatamab (n=63) had an overall response rate was 33%, with an estimated 84% maintaining the response for at least nine months.
Elranatamab is a bispecific BCMA-directed T-cell engaging antibody that binds BCMA on plasma cells, plasmablasts, and multiple myeloma cells and CD3 on T-cells leading to cytolysis of theBCMA-expressing cells. Elranatamab-bcmm activated T-cells, caused proinflammatory cytokine release, and resulted in multiple myeloma cell lysis.
The medication comes with a Boxed Warning for cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome, in addition to warnings and precautions for infections, neutropenia, hepatotoxicity and embryo-fetal toxicity.
The most common adverse reactions are CRS, fatigue, injection site reaction, diarrhea, upper respiratory tract infection, musculoskeletal pain, pneumonia, decreased appetite, rash, cough, nausea, and fever.
For more information about multiple myeloma, visit checkrare.com/multiple-myeloma/