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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