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Axicabtagene ciloleucel, sold under the brand name Yescarta, is a medication used for the treatment for large B-cell lymphoma that has failed conventional treatment. [8] T cells are removed from a person with lymphoma and genetically engineered to produce a specific T-cell receptor .
Axicabtagene ciloleucel (KTE-C19, ZUMA-3, YESCARTA) was an investigational therapy (for the treatment of adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL)) in which a patient's T cells were genetically modified to express a chimeric antigen receptor designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias. [11]
Kite, a unit of Gilead Sciences, announced that the US Food and Drug Administration (FDA) has approved its Yescarta T cell immunotherapy. The therapy is a first-of-its-kind treatment for adult ...
* Drugs@FDA includes information about drugs, including biological products, approved for human use in the United States (see FAQ), but does not include information about FDA-approved products regulated by the Center for Biologics Evaluation and Research (for example, vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products).
The FDA said in its letters to the companies on Monday that since the approval, it had identified adverse events and clinical trial reports describing T-cell malignancies.
Brexucabtagene autoleucel is a chimeric antigen receptor T cell therapy and is the first cell-based gene therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of mantle cell lymphoma.
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This policy was later challenged in court following FDA approval of a food coloring manufactured with a compound known to be carcinogenic, after separate testing indicated that the food coloring itself did not cause cancer in test animals. The United States Court of Appeals for the Sixth Circuit upheld the FDA's approval of the food coloring. [36]