FDA Approval of Brexucabtagene Autoleucel for B-Cell ALL: Bijal Shah, MD, MS

This content originally appeared on our sister site, OncLive.

OncLive spoke with Bijal Shah, MD, MS, associate member, Department of Malignant Hematology, Moffitt Cancer Center, to learn more about his thoughts on the FDA approval of brexucabtagene autoleucel (Tecartus) for patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL).

Brexucabtagene autoleucel was approved by the FDA on October 1, 2021 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 demonstrated a complete remission (CR; CR + CR with incomplete platelet recovery) rate of 71% (95% CI, 57%-82%; 56% CR, 15% CRi). Thirty-one percent 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.