U.S. Food and Drug Administration Approves First CAR T Cell Therapy for Mantle Cell Lymphoma: Brexucabtagene Autoleucel (TECARTUS)

On July 24, 2020, the U.S. Food and Drug Administration (FDA) announced it has approved the use of brexucabtagene autoleucel (TECARTUS, Kite, a Gilead Company) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).  This is the first chimeric antigen receptor (CAR) T cell therapy approved for MCL.

CAR T cell therapy provides engineered molecules called chimeric antigen receptors (CARs) that recognize and destroy antigens present on the surface of lymphoma cells. T cells are removed from patients and genetically modified to produce CARs. The genetically engineered CAR T cells are grown in the laboratory until they number in the billions and are then infused back into the patient.

“This approval marks the first CAR T cell therapy approved for mantle cell lymphoma patients and represents a new frontier in the treatment of this disease,” said Meghan Gutierrez, Chief Executive Officer at the Lymphoma Research Foundation. “In the past decade, researchers have made significant progress in our understanding of this disease and we have seen an increase in clinical trials for patients, which we hope will continue to improve treatment strategies and the options available to people with mantle cell lymphoma.  Today’s news builds upon this progress and provides hope to mantle cell patients and their loved ones.”

For more information on the FDA approval of brexucabtagene autoleucel (TECARTUS), visit the FDA’s website. To learn more about FDA approvals for MCL, visit lymphoma.org/MCLFDAUpdates.