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# Kite Therapy Approved for Mantle Cell Lymphoma
- URL: https://www.fdaweb.com/kite-therapy-approved-for-mantle-cell-lymphoma/
- Published: 2020-07-24T12:00:00.000Z
- Updated: 2026-09-14T16:22:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147277

FDA has granted Kite accelerated approval for Tecartus (brexucabtagene autoleucel), a chimeric antigen receptor T cell therapy for treating adult patients with relapsed or refractory mantle cell lymphoma (MCL). Approval is based on results from ZUMA-2, a single-arm, open-label study in which 87% of patients responded to a single infusion of Tecartus, including 62% who achieved a complete response, according to the company. On the safety side, 18% of patients experienced Grade 3 or higher cytokine release syndrome and 37% experienced Grade 3 or higher neurologic toxicities, it says. MCL is a rare form of non-Hodgkin lymphoma that forms from cells originating in the “mantle zone” of the lymph node and mostly affects men over the age of 60.