FDA approves first cell-based gene therapy for adult patients with relapsed or refractory mantle cell lymphoma

Summary: The Food and Drug Administration (FDA) announced the approval of a new treatment option for adults with relapsed or refractory mantle cell lymphoma (MCL), a form of non-Hodgkin lymphoma. The drug, called Tecartus (brexucabtagene autoleucel), is part of a new class of therapies that alter the genes in a person's own white blood cells to enable them to very effectively kill cancer.

Dr. Dan’s Takeaway: Tecartus is a one-time infusion that immediately becomes one of the most effective therapies for relapsed or refractory MCL. A complete response (total remission) was seen in 62% of patients, and 87% of patients had at least a partial response. A significant number of patients had severe side effects, including nervous system toxicity in 37% and cytokine release syndrome (CRS)* in 18% of patients.

*CRS occurs when the white blood cells in the body become very active and attack an invader, such as an infection or cancer. Because of the way Tecartus works, this is an expected side effect of this form of therapy.



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