On August 8, according to ENDPOINTS NEWS, the FDA has obtained sufficient clinical data from Kite's first CAR-T therapy axicabtagene ciloleucel (formerly known as KTE-C19) from the oncologist's research group, and on the FDA's AdComm meeting. Give the company a “passport†that means that the regulator will quickly get support for the launch of the product. Kite Pharma's axicabtagene ciloleucel is a cellular immunotherapy CAR-T product targeting CD19 with CD28 as a costimulatory domain. It isolates T cells from patients and uses engineered means to express chimeric antigen receptors (CARs) to target CD19 antigens. This antigen is frequently expressed on B cell lymphoma and leukemia cells. Therefore, through these CARs, engineered T cells are able to target cancer cells and kill them. In December 2015, axicabtagene ciloleucel received a FDA-approved breakthrough therapy for the treatment of diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL). These three non-Hodgkin's lymphomas also reflect the potential of this therapy. On May 26, 2017, the US FDA granted a BLA priority review application for Kite Pharma's CAR-T treatment candidate drug axicabtagene ciloleucel (formerly known as KTE-C19). The indication for this application was relapsed/refractory B-cell non-Hodgkin's lymphoma (NHL) that was not suitable for autologous stem cell transplantation. The PDUFA is scheduled to be approved on November 29, 2017. On July 31, 2017, Kite Pharma announced the submission of the MAA listing application for the first CAR-T product KTE-C19 (Axicabtagene Ciloleucel) to the European Medicines Agency (EMA). The indication for this application is diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) that are refractory or relapsed and are unable to perform autologous stem cell transplantation. . The Norwegian CAT-T cell treatment candidate CTL019 (trade name: tissuelecleucel-T), which is evenly matched, was also granted the priority review of the FDA Biopharmaceutical Licensing Application (BLA) on March 29, 2017. This approved CTL019 (trade name: tissuelecleucel-T) is suitable for relapsed and refractory B lymphocytic leukemia (B-ALL) in children and young adults. The FDA will make a decision on whether to go public before October 3. It can be seen that the world's first CAR-T cell therapy products are spent, and the competition is fierce. David Chang David Chang, head of research and development at Kite, said in a conference call on Tuesday, "The recent advisory committee meeting was very encouraging to us. The FDA has notified biotech regulators that it will not conduct a group review with a foreign expert on axi-cel. The FDA will Its manufacturing facilities and its treatment centres are inspected to expedite the review and final decision." Although the FDA's marketing decision for Axicabtagene Ciloleucel is due by November 29th, Kite Pharma said it is ready to go public, and once approved, will personalize CAR-T treatment for the patient as quickly as possible. Improve Immunity Plant Extract Improve Immunity Plant Extract,Ginseng Extract,Mulberry Powder,Seabuckthorn Powder Fufeng Sinuote Biotechnology Co.,Ltd. , https://www.sntbiology.com
