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The U.S. Food and Drug Administration (FDA) has approved Tecartus (brexucabtagene autoleucel), a chimeric antigen receptor (CAR) T cell therapy, to treat adults with mantle cell lymphoma (MCL).

MCL is a rare form of non-Hodgkin’s lymphoma in which  B-cells become cancerous and form tumors in the lymph nodes that can quickly spread to other regions.

The approved treatment is unique in that each dose of brexucabtagene autoleucel  will be  customized using the patient’s own T cells that will be genetically modified to include a new gene that facilitates the targeting and killing of the lymphoma cells.

The approval of brexucabtagene autoleucel was largely based on a multicenter clinical trial of 60 adults with refractory or relapsed MCL who were followed for at least six months after their first objective disease response. The complete remission rate after treatment with brexucabtagene autoleucel  was 62%, with an objective response rate of 87%.

The most common adverse event ( Grade 3 or higher) are anemia, neutropenia, thrombocytopenia, hypotension, hypophosphatemia, encephalopathy, leukopenia, hypoxia, pyrexia, hyponatremia, hypertension, infection-pathogen unspecified, pneumonia, hypocalcemia and lymphopenia.

The cell-based gene therapy comes with a boxed warning for cytokine release syndrome (CRS). A Risk Evaluation and Mitigation Strategy (REMS) has been approved for Tecartus (brexucabtagene autoleucel). For more information, visit YescartaTecartusREMS.com.

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