Elranatamab Approval for Treatment of Multiple Myeloma
The US Food and Drug Administration (FDA) has granted accelerated approval to Elranatamab, a tailor-made biologic agent for the treatment of relapsed or persistent Multiple Myeloma.
The bispecific antibody, targeted to the B Cell Maturation Antigen CD-3, was prioritized in February and has already been previously announced by Pfizer as a breakthrough development in the treatment of relapsed or persistent Multiple Myeloma.
The FDA’s approval was based on the phase II MagnetisMM-3 study. The response in the single-arm study and the duration of this response led to the approval. The study found significant results with Elranatamab in patients with recurrent and persistent Multiple Myeloma who had received prior treatment.
Elranatamab is given subcutaneously at a dose of 76 mg weekly over a 28-day cycle. The priming regimen includes doses of 12 mg and 32 mg on day 1 and day 4 of Cycle 1, respectively. Patients who receive at least six cycles and show a partial response for at least two months have their dosing interval changed to every two weeks.
Elranatamab carries a black box warning for Cytokine Release Syndrome and Neurologic toxicity. It should also be noted that it can cause infections, neutropenia, hepatotoxicity and embryo-fetal toxicity. Therefore, the agent may only be available through a limited Risk Evaluation and Mitigation Strategy (REMS).
Reference:
FDA Approves Elranatamab for Multiple Myeloma – Medscape – Aug 14, 2023.
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