FDA Approval Insights: Idecabtagene Vicleucel for Relapsed/Refractory Multiple Myeloma

Welcome to OncLive On Air^TM! I’m your host today, Caroline Seymour.

OncLive On Air^TM is a podcast from OncLive, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions. 

In today’s episode, we had the pleasure of speaking with Nikhil C. Munshi, MD, director of Basic and Correlative Science at the Jerome Lipper Multiple Myeloma Center, Kraft Family Chair and senior physician at Dana-Farber Cancer Institute, as well as a professor of medicine at Harvard Medical School, to discuss the FDA approval of idecabtagene vicleucel (ide-cel; Abecma) in relapsed/refractory multiple myeloma.

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.

In our exclusive interview, Munshi discussed 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.