FDA approvals

July 27, 2020

Tecartus Approved for Treatment of Mantle Cell Lymphoma

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MONDAY, July 27, 2020 -- Tecartus (brexucabtagene autoleucel) received approval for the treatment of mantle cell lymphoma (MCL) in patients who have not responded to other treatment types or relapsed following treatment, the U.S. Food and Drug Administration announced Friday.

Tecartus is a chimeric antigen receptor (CAR) T cell therapy and the first cell-based gene therapy approved for the treatment of MCL. Each dose of the drug is customized based on a patient's immune system.

The approval was based on safety and efficacy data from a multicenter clinical trial of 60 adults with refractory or relapsed MCL. Patients were followed for at least six months after their first objective disease response. Sixty-two percent of patients achieved complete remission after treatment with Tecartus, and the objective response rate was 87 percent.

A boxed warning on the drug's label indicates there is a risk for cytokine release syndrome and neurologic toxicities. The most commonly reported side effects included serious infections, low blood cell counts, and a weakened immune system, all of which typically occur within the first one or two weeks after treatment. Because of these risks, Tecartus was approved with a risk evaluation and mitigation strategy, with risk mitigation measures identical to those of another CAR-T cell therapy, Yescarta. The treatment manufacturer is required by the FDA to conduct a postmarketing observational study of patients treated with Tecartus.

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