Kite filed a biologics license application for T-cell therapy KTE-X19 with the FDA
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Last Update: 2020-06-07
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Source: Internet
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Author: User
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recently, Gilead Sciences' KiteCompany
(http:// announcedthat it had submitted a biologic license application (BLA) for the device-based antigen receptor (CAR) T-cell therapy KTE-X19 to the U.SFDA(http://for the treatment of adult recurrent or refractory lymphoma (MCL)about KTE-X19
KTE-X19 is an autonomous CAR-T therapy that targets CD19, using an XLP manufacturing process that includes T-cell screening and lymphocyte enrichment, and for some B-cell malignancies with signs of circulating lymphocytes, lymphocytic enrichment is a necessary step in the manufacture of CAR-T therapy, KTE-X19 has been awarded the FDA's breakthrough therapy andhttp://
granted theThe submission of KTE-X19 is based on data from the
(http://of the
Phase 2, which was evaluated by the Independent Radiological Review Board (IRRC) and showed an overall mitigation rate of 93%, including 67% full mitigation, after a single infusion of KTE-X193 or higher levels of cytokine release syndrome (CRS) and neurological events were found in the safetyanalysis(http://, respectively, in 15% and 31% of patientsThere were no level 5 CRS or neurological eventsKite plans to submit a marketing authorization application for KTE-X19 in the European Union in early 2020, having previously been granted by the FDA's Breakthrough Treatment Designation (BTD) and the European Medicines Agency (EMA) Priority Drug (PRIME) to treat recurrent or refractory MCLs
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