FDA Approves BMS and J&J CAR-T Cell Therapies for the Earlier Treatment of Multiple Myeloma | Goodwin
On April 4, 2024, Bristol Myers Squibb (“BMS”) and 2seventy bio, Inc. announced that the FDA has approved ABECMA (idecabtagene vicleucel) for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody. ABECMA is a CAR T cell therapy that recognizes and binds to B-cell maturation antigen (“BCMA”) on the surface of multiple myeloma cells leading to CAR T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells. The product was jointly developed and commercialized in the United States as part of a co-development, co-promotion, and profit share agreement between BMS and 2seventy bio, and was originally approved by the FDA in March 2021 for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy. The FDA’s new approval is based on results from a pivotal, Phase 3, open-label, global, randomized, controlled trial and according to the BMS press release expands on ABECMA’s previous indication, “making it available in earlier lines to patients who have relapsed or become refractory after exposure to these three main classes of treatment (triple-class exposed), after two prior lines of therapy.”
On April 5, 2024, Johnson & Johnson (“J&J”) announced that the FDA has approved its BCMA-directed, CAR T-cell therapy CARVYKTI (ciltacabtagene autoleucel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide. The approval is based on results from J&J’s Phase 3 CARTITUDE-4 trial, which were presented at the 2023 American Society of Clinical Oncology (“ASCO”) Annual Meeting and published in The New England Journal of Medicine. According to J&J’s press release, this approval means CARVYKTI “becomes the first and only B-cell maturation antigen (BCMA)-targeted therapy approved for the treatment of patients with multiple myeloma as early as first relapse.” CARVYKTI was originally approved by FDA in February 2022 for treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy.
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