Tecartus (brexucabtagene autoleucel) received FDA approval for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
Tecartus is sponsored by Kite Pharma, Inc.
Efficacy was evaluated in ZUMA-3 (NCT02614066), a single-arm, multicenter trial that evaluated Tecartus, a CD19-directed chimeric antigen receptor CAR T-cell therapy, in adults with relapsed or refractory B-cell precursor ALL. Patients received a single infusion of Tecartus following completion of lymphodepleting chemotherapy.
Of the 54 patients evaluable for efficacy, 28 (52%; 95% CI: 38-66) achieved complete response within 3 months. With a median follow-up for responders of 7.1 months, the median duration of CR was not reached; the duration of CR was estimated to exceed 12 months for more than half the patients.
This application was granted FDA priority review, breakthrough designation, and orphan drug designation.
