On May 26, local time, Kite Pharma announced that the US FDA has accepted the BLA priority review application for its CAR-T treatment candidate 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.
Not long ago (May 8th), Kite Pharmaceuticals (KITE) announced in a first-quarter investor conference call that the company developed a non-Hodgkin's lymphoma for its CAR-T treatment drug KTE-C19. After (NHL), the patient developed symptoms of cerebral edema and eventually died two days after treatment. This means that the FDA review is not affected by small probability events.
Kite Pharma's axicabtagene ciloleucel is a cellular immunotherapy CAR-T product targeting CD19 with CD28 as a costimulatory domain. It separates T cells from patients and uses engineering methods to make these The cells express a chimeric antigen receptor (CAR) that targets the CD19 antigen. Through these CARs, engineered T cells are able to target cancer cells and kill them.
The latest research results were announced at the AACR 2017 conference on April 3, 2017. In a phase 2 clinical trial called ZUMA-1, Kite's CAR-T therapy was objective response rate. The primary clinical endpoint was reached. After receiving a single axicabtagene ciloleucel infusion, up to 82% of patients experienced remission. At a median of 8.7 months of follow-up, 44% were still in remission and 39% were in complete remission. The most common side effects of grade 3 and above are anemia, and symptoms such as neutropenia.
Previously, the drug was approved by the FDA in December 2015 for the treatment of diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B cells. Lymphoma (PMBCL), three non-Hodgkin's lymphomas. In March of this year, Kite announced the completion of the axicabtagene ciloleucel Biological Product Licensing Application (BLA) rolling declaration. The priority evaluation status approved today is FDA-set PDUFA date November 29, 2017.
On the highly competitive CAR-T track, not long ago (March 29), Novartis official website announced that the FDA approved the biopharmaceutical license application for its company's CAR-T cell therapy candidate CTL019 (trade name: tissue lecleucel-T) (BLA) enters priority review. CTL019 is indicated for relapsed and refractory B lymphocytic leukemia (B-ALL) in children and young adults. Outstanding in a phase II clinical trial of a group of amazing CTL019 published by Novartis, data showed that patients treated with CTL019 were completely relieved in children with relapsed/refractory acute lymphoblastic leukemia (r/r ALL) and young adults. The rate reached 93% (n=55/59).
Two months apart, both Novartis and Kite received the FDA's “Priority Review†vouchers in the CAR-T field. If the FDA review is approved, it means that the world's first Car-t treatment product will be born as soon as the end of the year. This will bring significant benefits to the R&D institutions in the industry.
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