Brexucabtagene autoleucel receives FDA approval for the treatment of relapsed/refractory mantle cell lymphoma

On July 24, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to brexucabtagene autoleucel, formerly KTE-X19, for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL).^1,2

Brexucabtagene autoleucel is a chimeric antigen receptor (CAR) T-cell therapy targeting the CD19 antigen on the surface of lymphoma cells. The FDA approval, that follows a priority review and FDA breakthrough therapy designation, was based on data from the ongoing ZUMA-2 trial in patients with R/R MCL who had previously received anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antibody therapy, and a Bruton tyrosine kinase inhibitor. Results demonstrated an objective response rate of 87% and a complete response rate of 62%.^1,2

In the trial, among patients evaluable for safety (n = 82), 91% experienced cytokine release syndrome (CRS) including 18% with ≥ Grade 3 CRS, and 81% experienced neurologic events including 37% with ≥ Grade 3. Due to the risk of CRS and neurologic toxicities, brexucabtagene autoleucel is only available through a restricted program under a risk evaluation and mitigation strategy.¹

A manufacturing success rate of 96% was reported in the ZUMA-2 trial, with a median manufacturing time of 15 days from leukapheresis to product delivery.

Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) will be a certified treatment center for the therapy.²

Brexucabtagene autoleucel is under review in the European Union, and it is under investigation in phase I/II trials involving patients with acute lymphoblastic leukemia (NCT02614066) and chronic lymphocytic leukemia (NCT03624036).¹