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    Home > Biochemistry News > Biotechnology News > Ready-to-use T cell therapy enters the regulatory review stage for the first time, significantly improving patient survival

    Ready-to-use T cell therapy enters the regulatory review stage for the first time, significantly improving patient survival

    • Last Update: 2022-01-12
    • Source: Internet
    • Author: User
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    On November 30, 2021, Atara Biotherapeutics announced that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for the T cell immunotherapy tabelecleucel (tab-cel) for the treatment of EB virus (EBV) related Post-transplant lymphoproliferative disease (EBV+PTLD)
    The press release states that this is the world's first ready-to-use allogeneic T cell therapy to be reviewed by regulatory agencies


    EBV+PTLD is a type of lymphoma, a serious blood cancer, which may occur after solid organ transplantation (SOT) or allogeneic hematopoietic cell transplantation (HCT)
    The median overall survival of EBV+PTLD patients after HCT who failed first-line treatment was 16-56 days, while the 1-year and 2-year survival rates of high-risk EBV+PTLD patients after SOT were 36% and 0%, respectively


    Tab-cel is a ready-to-use allogeneic T cell immunotherapy
    In addition to the treatment of EBV+PTLD patients who have failed rituximab therapy, the therapy is also planned to treat other EBV-related blood cancers and solid tumors, including nasopharyngeal carcinoma

    In February 2015, the US FDA granted tab-cel a breakthrough therapy designation for the treatment of EBV+PTLD after HCT


    This application is based on positive data obtained from an ongoing phase 3 clinical trial.
    As of May 2021, 38 evaluable patients (24 after SOT and 14 after HCT) had an average ORR of 50% (19 /38, 95% CI: 33.
    4, 66.
    6), including complete remission (CR; n=5, SOT; n=5, HCT) and partial remission (PR; n=7, SOT; n=2, HCT)

    Of the 19 patients who achieved remission, 11 had a duration of remission (DOR) of more than 6 months, and the median DOR had not yet been reached

    The safety aspect is consistent with previously published data, and no new signals or problems have been reported

    There were no adverse reactions such as graft-versus-host disease (GvHD), organ rejection, infusion reactions, or tab-cel-related cytokine release syndrome


    ▲Tab-cel Phase 3 clinical trial results (picture source: Atara Biotherapeutics official website)

    Reference materials:

    [1] European Medicines Agency (EMA) Validates Atara Biotherapeutics' Marketing Authorization Application for Tabelecleucel for the Treatment of Epstein-Barr Virus-Positive Post-Transplant Lymphoproliferative Disease.
    Retrieved November 30, 2021, from https:// /news/home/20211130005204/en

    (The original text has been deleted)

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