OBR OncologyFDA Grants Accelerated Approval to Elranatamab for Relapsed or Refractory Multiple Myeloma

Adults with relapsed or refractory multiple myeloma who have tried at least four different forms of therapy are eligible for the approval. These earlier treatments included monoclonal antibodies against CD38, immunomodulatory drugs, and proteasome inhibitors.

The FDA has granted accelerated approval to elranatamab-bcmm (Elrexfio) for adults with relapsed or refractory multiple myeloma. This decision comes after a careful review of the phase 2 MagnetisMM-3 clinical trial results, offering a new therapeutic option for patients who have undergone extensive prior treatments.

Key Points:

• Approval based on MagnetisMM-3 trial, including 97 patients who had not previously undergone BCMA-directed treatment.
• Objective response rate (ORR) of 57.7% in primary efficacy population; median duration of response (DOR) not reached.
• Durable response rate at six months was 90.4%; at nine months, it was 82.3%.
• Second bispecific antibody to receive accelerated approval this month.
• Boxed Warning for potentially life-threatening or fatal cytokine release syndrome (CRS), neurologic toxicity, including immune effector cell-associated neurotoxicity (ICANS).

Additional Points:

• Findings also include a cohort of 64 patients with ORR of 33% over a median follow-up of 10.2 months.
• Common adverse responses include CRS, fatigue, injection site reaction, diarrhea, and more.
• Recommended dosing includes a step-up dose followed by weekly and bi-weekly intervals.
• Available only through a restricted program under ELREXFIO REMS.

Conclusion:

• Elranatamab provides a significant new option for heavily pre-treated multiple myeloma patients, with promising response rates and an established safety profile, but with noted risks and adverse responses.

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