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Drugs & Targets

FDA approves Tecartus for relapsed or refractory B-cell precursor ALL

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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.

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