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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).
Google Charts is an online tool that is used to create charts and graphs. It uses HTML5 and SVG to function on multiple browsers and devices without extra plugins or software. It is known for its wide range of chart options and features, which are explained on the official Google Charts website. [1]
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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.
Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and Competition Act (Hatch-Waxman Act). The Hatch-Waxman Act was created to '"strike a balance between two competing policy interests: