The FDA granted accelerated approval to brexucabtagene autoleucel (formerly KTE-X19), a chimeric antigen receptor (CAR) T-cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). The approval marks the first CAR T-cell treatment approved for MCL.
The decision was based on ZUMA-2, a single-arm, multicenter, open-label trial of 60 adults with relapsed/refractory MCL, who were monitored for at least 6 months after first objective disease response. The objective response rate after a single infusion of brexucabtagene autoleucel was 87%, with 62% of patients achieving a complete response. Among patients evaluated for treatment safety, 18% experienced grade ≥3 cytokine release syndrome (CRS) and 37% experienced grade ≥3 neurologic toxicities.
Findings from ZUMA-2 were originally reported at the 2019 ASH Annual Meeting.
The treatment label carries a boxed warning for CRS. The most common adverse events associated with brexucabtagene autoleucel include serious infection, low blood cell counts, and a weakened immune system.
The treatment also was granted breakthrough therapy and orphan drug designations.