FDA Approves New CAR T Therapy, First for Mantle Cell Lymph
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U.S. Food and Drug Administration approved Tecartus (brexucabtagene autoleucel), a cell-based gene therapy for treatment of adult patients diagnosed with mantle cell lymphoma (MCL).

Tecartus, a chimeric antigen receptor (CAR) T cell therapy, is the first cell-based gene therapy approved by the FDA for the treatment of MCL.

MCL is a rare form of cancerous B-cell non-Hodgkin’s lymphoma that usually occurs in middle-aged or older adults.

In patients with MCL, B-cells change into cancer cells that start to form tumors in the lymph nodes and quickly spread to other areas of the body.

Each dose of Tecartus is a customized treatment created using a patient’s own immune system to help fight the lymphoma.

The patient’s T cells, a type of white blood cell, are collected and genetically modified to include a new gene that facilitates the targeting and killing of the lymphoma cells. These modified T cells are then infused back into the patient.

The most common side effects of Tecartus include serious infections, low blood cell counts and a weakened immune system.

Source: https://www.fda.gov/news-events/press-announcements/fda-approves-first-cell-based-gene-therapy-adult-patients-relapsed-or-refractory-mcl
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