Kit's car-t therapy is qualified for priority review

Today, kit, a subsidiary of Gilead Sciences, announced that the US FDA has accepted its biological product licensing application (BLA) for car-t therapy kte-x19 to treat patients with relapsed / refractory mantle cell lymphoma (MCL) The FDA also granted the treatment priority review qualification, and is expected to provide a response by August 10 this year If approved, kit will be the first company to have multiple commercial car-t therapies, the press release said MCL is a rare non-Hodgkin's lymphoma It is a cell carcinogenesis of the "mantle" region of lymph nodes, which usually affects men over 60 years old Although there are many treatments for this type of cancer, patients will eventually become resistant to the existing treatments, so innovative treatment options are needed Kte-x19 is an auto car-t therapy targeting CD19 It uses a XLP manufacturing process including T cell screening and lymphocyte enrichment For some B-cell malignancies with circulating lymphoblastic signs, lymphocyte enrichment is a necessary step in the manufacture of car-t therapy At present, kte-x19 is being used in 1 / 2 phase clinical trials to treat patients with acute lymphoblastic leukemia (all), chronic lymphoblastic leukemia (CLL), and MCL Kte-x19 has been recognized by FDA as a breakthrough therapy and EMA as a prime drug R & D plan and progress of kte-x19 (photo source: kite official website) The BLA submission is based on positive data from a phase 2 clinical study called zuma-2 The MCL patients who participated in the trial have received 5 kinds of pre-treatment, including chemotherapy, anti-CD20 monoclonal antibody therapy, Btk inhibitor ibrutinib or acalabrutinib, but the patients developed drug resistance or disease recurrence The results showed that in 60 patients with MCL who could evaluate the efficacy, the overall remission rate (ORR) was 93%, of which 67% achieved complete remission (CR) At a median follow-up of 12.3 months, 57% of the patients were still in remission Of the 28 patients who were initially treated (with a follow-up of at least 24 months), 43% were still alive and in a state of continuous remission without any other treatment reference material: [1] U.S FDA Grants Priority Review for Kite’s KTE-X19 Biologics License Application (BLA) in Relapsed or Refractory Mantle Cell Lymphoma, Retrieved February 10, 2020, from https://’s-KTE-X19 [2] Kite Submits Biologics License Application to U.S Food and Drug Administration for Company’s Second CAR T Cell Therapy, Retrieved February 10, 2020, from https:// Note: the original text has been deleted A kind of