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Shaji K. Kumar, MD

Prashant Kapoor, MD, FACP


Expanded FDA Approval for Idecabtagene Vicleucel in Relapsed or Refractory Multiple Myeloma

By: JNCCN 360 Staff
Posted: Monday, April 8, 2024

On April 4, Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) approved the use of idecabtagene vicleucel (Abecma) for treatment of adults with relapsed or refractory multiple myeloma after two or more prior lines of therapy (including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody). Idecabtagene vicleucel is administered as a one-time infusion, with a new recommended dose range of 300 to 510 x 106 chimeric antigen receptor (CAR)-positive T cells.

This expanded approval, which makes this immunotherapy available in earlier lines of patients for this type of myeloma, is based on the results of the phase III KarMMa-3 trial. This randomized trial of 254 patients compared idecabtagene vicleucel with standard regimens in patients with relapsed or refractory multiple myeloma who have received two to four prior lines of treatment.

At an estimated median duration of follow-up of 15.9 months, idecabtagene vicleucel more than tripled the primary endpoint of progression-free survival compared with standard regimens, with a median progression-free survival of 13.3 months vs 4.4 months, respectively (hazard ratio = 0.49; 95% confidence interval [CI] = 0.38–0.64; P < .00010). This represented a 51% reduction in the risk of disease progression or death with the immunotherapy. In addition, 71% of those treated with idecabtagene vicleucel achieved a response, and 39% achieved a complete or stringent complete response.

Idecabtagene vicleucel has had a consistent safety profile, with mostly low-grade cytokine-release syndrome and neurotoxicity. Any-grade cytokine-release syndrome occurred in 89% of patients, including 7% who experienced grade ≥ 3 cytokine-release syndrome. Any-grade neurotoxicity was observed in 40% of those given the immunotherapy in the KarMMa and KarMMa-3 trials. This immunotherapy carries a boxed warning on cytokine-release syndrome, neurologic toxicities, hemophagocytic syndrome and macrophage activation syndrome, prolonged cytopenia, and secondary hematologic malignancies.

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