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    Association details:
    Biomarker:No biomarker
    Cancer:Follicular 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:
    Kite Pharma Press Release
    Title:

    U.S. FDA APPROVES YESCARTA FOR RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY

    Published date:
    03/05/2021
    Excerpt:
    Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Yescarta (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
    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: A2 - Guideline
    New
    Source:
    NCCN
    Excerpt:
    Follicular Lymphoma: Suggested treatment regimens…Anti-CD19 CAR T-cell therapy (only after ≥2 prior chemoimmunotherapy regimens...axicabtagene ciloleucel
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Kite Pharma Press Release
    Title:

    YESCARTA® IS FIRST CAR T-CELL THERAPY TO DEMONSTRATE HIGH RESPONSE RATES AND DURABLE CLINICAL BENEFIT IN A PIVOTAL INDOLENT NON-HODGKIN LYMPHOMA STUDY

    Published date:
    12/05/2020
    Excerpt:
    Kite, a Gilead Company...U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) and granted Priority Review designation for Yescarta for the treatment of relapsed or refractory follicular lymphoma (FL) and marginal zone lymphoma (MZL)...