Posted by Michael Wonder on 02 Oct 2021
FDA approves brexucabtagene autoleucel for relapsed or refractory B-cell precursor acute lymphoblastic leukemia
1 October 2021 - Today, the Food and Drug Administration approved brexucabtagene autoleucel (Tecartus, Kite Pharma) for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia.
Efficacy was evaluated in ZUMA-3, a single-arm multi-centre trial that evaluated brexucabtagene autoleucel, a CD19 directed chimeric antigen receptor T-cell therapy, in adults with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia. Patients received a single infusion of brexucabtagene autoleucel following completion of lymphodepleting chemotherapy.
