Dr. Wang on the FDA Approval of Brexucabtagene Autoleucel in MCL

Michael Wang, MD, a professor in the Department of Lymphoma and Myeloma at The University of Texas MD Anderson Cancer Center, discusses the FDA approval of brexucabtagene autoleucel (Tecartus; formerly KTE-X19) in mantle cell lymphoma (MCL).

On July 24, 2020, the FDA approved the CAR T-cell therapy brexucabtagene autoleucel as a treatment for adult patients with relapsed/refractory MCL. The approval will change the paradigm in MCL for the better, says Wang.

The approval is based on findings from the phase 2 ZUMA-2 trial, in which a single infusion of the CAR T-cell product elicited an 87% objective response rate, as assessed by an Independent Radiologic Review Committee, in patients with relapsed/refractory MCL; additionally, there was a 62% complete response (CR) rate. Patients in the trial received a median of 3 prior lines of therapy. Historical response rates in this setting range from 20% to 25%, says Wang.

Moreover, grade 3 or greater cytokine release syndrome (CRS) and neurologic events were reported in 18% and 37% of patients, respectively, and no grade 5 CRS or neurologic events occurred.