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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]
The Gilead (GILD) company said that the US regulator’s decision was based on ZUMA-5, a single-arm, open-label study, that demonstrated 91% of patients with relapsed or refractory FL (n=81 ...
The Prescribing Information follows one of two formats: "physician labeling rule" format or "old" (non-PLR) format. For "old" format labeling a "product title" may be listed first and may include the proprietary name (if any), the nonproprietary name, dosage form(s), and other information about the product. The other sections are as follows:
CAR-T therapies are approved under several products: Abecma, Breyanzi, Carvykti, Kymriah, Tecartus and Yescarta. FDA warns certain therapy to treat cancer may cause secondary cancer Skip to main ...
The results of the testing program are codified in an FDA-approved public document that is called the product label, package insert or Full Prescribing Information. [10] The prescribing information is widely available on the web from the FDA, [11] drug manufacturers, and frequently inserted into drug packages. The main purpose of a drug label ...
A logarithmic chart allows only positive values to be plotted. A square root scale chart cannot show negative values. x: the x-values as a comma-separated list, for dates and time see remark in xType and yType; y or y1, y2, …: the y-values for one or several data series, respectively. For pie charts y2 denotes the radius of the corresponding ...
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