Phase 3 trial shows 51 percent reduction in the risk for disease progression or death in triple-class exposed patients<\/p>\n<\/h3>\n
By Lori Solomon HealthDay Reporter<\/b><\/p>\n
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TUESDAY, April 9, 2024 (HealthDay News) — The U.S. Food and Drug Administration has approved Abecma (idecabtagene vicleucel) as a personalized CAR T-cell therapy for triple-class exposed relapsed or refractory multiple myeloma.<\/p>\n
The approval is for the treatment of adult patients 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. Abecma is a one-time infusion, with a new recommended dose range of 300 to 510 x 106<\/sup>\u00a0CAR-positive T cells. Boxed warnings for Abecma include cytokine release syndrome, neurologic toxicities, hemophagocytic lymphohistiocytosis\/macrophage activation syndrome, prolonged cytopenia, and secondary hematological malignancies.<\/p>\n The approval was based on data from the phase 3 KarMMa-3 trial of 254 patients. At a median follow-up of 15.9 months, Abecma more than tripled the primary end point of progression-free survival versus standard regimens, with a median progression-free survival of 13.3 months versus 4.4 months (hazard ratio, 0.49). Overall response rates were also significantly improved with Abecma, with 71 percent of patients treated with Abecma achieving a response and 39 percent achieving a complete or stringent complete response compared with 42 and 5 percent, respectively, of those receiving standard regimens. Responses to Abecma were durable, with a median duration of response of 14.8 months (or 20 months for patients who derived a complete response or better).<\/p>\n “With this approval, these patients now have an opportunity to be treated at an earlier line of therapy with a potentially transformative therapy that offers significantly improved progression-free survival for this difficult-to-treat disease that has had no established treatment approach,” Al-Ola A. Abdallah, M.D., chair of the U.S. Myeloma Innovations Research Collaborative, said in a statement.<\/p>\n Approval of Abecma was granted to Bristol Myers Squibb and 2seventy bio.<\/p>\n