Dr. Shah on the FDA Approval of Brexucabtagene Autoleucel for B-Cell ALL

Bijal Shah, MD, MS, an associate member in the Department of Malignant Hematology at Moffitt Cancer Center, discusses the FDA approval of brexucabtagene autoleucel (Tecartus) for patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL).

On October 1, 2021, the FDA approved brexucabtagene autoleucel for patients with relapsed/refractory B-cell precursor ALL. The approval was based on findings from the phase 1/2 ZUMA-3 trial (NCT02614066), which showed that the complete remission (CR; CR + CR with incomplete platelet recovery) rate was 71% (95% CI, 57%-82%; 56% CR, 15% CRi); 31% of responders had ongoing responses. The median duration of response, relapse-free survival, and overall survival was 12.8 months (95% CI, 8.7-not estimable [NE]), 11.6 months (95% CI, 2.7-15.5), and 18.2 months (95% CI, 15.9-NE), respectively.

These data, apart from powerful, are unheard of in such a heavily pretreated population of patients with ALL, says Shah. The magnitude of OS benefit seen with brexucabtagene autoleucel in this patient population has never been achieved in prior trials in this setting, marking a significant advance for the field, concludes Shah.