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    Association details:
    Biomarker:No biomarker
    Cancer:Mediastinal B Cell Lymphoma
    Drug:Yescarta (axicabtagene ciloleucel) (CD19-targeted CAR-T immunotherapy)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    Gilead Press Release
    Title:

    Kite Joint Venture - Fosun Kite - Gains the First CAR T-cell Therapy Approval in China

    Published date:
    06/23/2021
    Excerpt:
    Kite, a Gilead Company, announced that...has received approval from the China National Medical Products Administration (NMPA) for axicabtagene ciloleucel for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma.
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    Daiichi Sankyo Press Release
    Title:

    YESCARTA Approved in Japan for Treatment of Patients with Relapsed/Refractory Large B-Cell Lymphomas

    Published date:
    01/22/2021
    Excerpt:
    Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced the Japan Ministry of Health, Labour and Welfare (MHLW) has approved YESCARTA (axicabtagene ciloleucel)...YESCARTA has been approved in Japan for treatment of patients with relapsed/refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed follicular lymphoma or high-grade B cell lymphoma.
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    European Medicines Agency
    Published date:
    08/23/2018
    Excerpt:
    Yescarta is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy.
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    FDA
    Excerpt:
    YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
    Evidence Level:
    Sensitive: A2 - Guideline
    New
    Source:
    NICE
    Title:

    Axicabtagene ciloleucel for treating diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma after 2 or more systemic therapies

    Excerpt:
    Axicabtagene ciloleucel is recommended, within its marketing authorisation, as an option for treating relapsed or refractory diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma in adults after 2 or more systemic therapies.