Dr. Munshi on the FDA Approval of Idecabtagene Vicleucel in Multiple Myeloma

Nikhil C. Munshi, MD, discusses the FDA approval of idecabtagene vicleucel (ide-cel; Abecma) 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.

On March 26, 2021, the FDA approved ide-cel as the first BCMA-directed 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 is 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. The approval represents a significant advance that will take treatment to the next level, says Munshi.

Ide-cel is approved as a one-time infusion with a recommended dose range of 300 to 460 x 10⁶ CAR-positive T cells. The therapy, which is one of the most active treatments now available in multiple myeloma, is going to be incorporated very quickly into clinical practice given the deep and durable responses and manageable toxicity that was reported in the KarMMa trial, says Munshi. The treatment will be a clear choice for eligible patients who require treatment in the fourth- or later-line settings, concludes Munshi.