July 24, 2020

The U.S. FDA has approved Tecartus™ (brexucabtagene autoleuce), manufactured by Gilead, to treat relapsed or refractory mantle cell lymphoma (MCL) in adults. Tecartus is the third CAR-T therapy ever approved by the FDA, and the first for MCL.

Mantle cell lymphoma is a rare form of cancer that accounts for up to 7% of all non-Hodgkin lymphoma diagnoses in the United States. It occurs when the body’s B-cells, a type of white blood cell, become cancerous. Although treatable, MCL is not curable and can be extremely aggressive once a patient relapses following previous therapy.

In a clinical study, Tecartus delivered an objective response rate of 87% after a single infusion, with 62% of patients achieving a complete response. The median duration of response has not yet been reached. CAR-T therapies work by genetically engineering the patient’s own T cells, a type of immune cell, to target and fight a particular type of cancer. Recommended dosing is based on body weight. Tecartus is administered as a one-time intravenous infusion at a healthcare facility.

A black box warning cautions that, like other CAR-T therapies, Tecartus carries a risk of potentially fatal cytokine release syndrome (CRS). There is also a black box warning for potentially fatal neurologic toxicities, which may occur concurrently with CRS or after CRS resolution. Tecartus is available only through a Risk Evaluation and Mitigation Strategy (REMS) program.

Launch has not yet been announced, though Tecartus is expected to have a wholesale acquisition cost (WAC) of $373,000 per treatment.

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