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FDA Approvals, News & UpdatesLeukemia

Tecartus, a Gene Therapy, Now Approved for Patients with Relapsed B-Cell Precursor Acute Lymphoblastic Leukemia

In October 2021, the FDA approved a second indication for Tecartus (brexucabtagene autoleucel), a novel, genetically modified CAR T-cell therapy, for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
December 2021 Vol 7 No 6

On October 1, 2021, the FDA approved a new indication for Tecartus (brexucabtagene autoleucel; from Kite Pharma), a CD19-directed CAR T-cell therapy, for the treatment of adults with relapsed (coming back) or refractory (not responding to therapy) B-cell precursor acute lymphoblastic leukemia (ALL).

This approval was based on the ZUMA-3 study, a single-arm multicenter clinical trial of adults with relapsed or refractory B-cell precursor ALL. Patients received a single infusion of Tecartus after completion of lymphodepleting chemotherapy.

Of the 54 patients who were evaluable for efficacy, 28 (52%) patients had a complete response within 3 months. At an average follow-up of 7.1 months, the average duration of complete response was not reached (meaning many patients were still responding); the duration of complete response was estimated to be more than 12 months for more than 50% of the patients.

The most common non-laboratory side effects included fever, cytokine-release syndrome, hypotension, encephalopathy, tachycardias, nausea, chills, headache, fatigue, febrile neutropenia, diarrhea, musculoskeletal pain, hypoxia, rash, edema, tremor, infection with pathogen unspecified, constipation, decreased appetite, and vomiting.

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Last modified: March 10, 2022

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