Dr. Munshi discusses the significance of the FDA approval of ide-cel in relapsed/refractory multiple myeloma, data from the KarMMa trial, which served as the basis for the approval, and next steps for CAR T-cell therapy in the field.
On March 26, 2021, the FDA approved ide-cel as the first BCMA-directed chimeric antigen receptor (CAR) T-cell therapy for patients with relapsed/refractory multiple myeloma after 4 or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
The approval was based on findings from the pivotal, phase 2 KarMMA trial, in which ide-cel elicited an overall response rate of 72% (95% CI, 62%-81%) and a stringent complete response rate of 28% (95% CI, 19%-38%) in an efficacy evaluable population (n = 100) of patients with relapsed/refractory myeloma who had received at least 4 prior treatments.
Ide-cel is approved as a one-time infusion with a recommended dose range of 300 to 460 x 106 CAR-positive T cells.
Published
June 21, 2021
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Dr. Munshi received his MD from Maharaja Sayjirao University, India, in 1984. He completed his postgraduate training in Internal Medicine at SSG Hospital and Maharaja Sayjirao University, followed by fellowships at Johns Hopkins Oncology Center...