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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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