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    Association details:
    Biomarker:No biomarker
    Cancer:B Acute Lymphoblastic Leukemia
    Drug:Tecartus (brexucabtagene autoleucel) (CD19-targeted CAR-T immunotherapy)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    Kite Pharma
    Title:

    U.S. FDA APPROVES KITE’S TECARTUS® AS THE FIRST AND ONLY CAR T FOR ADULTS WITH RELAPSED OR REFRACTORY B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA

    Published date:
    10/01/2021
    Excerpt:
    Kite, a Gilead Company...today announced the U.S. Food and Drug Administration (FDA) has granted approval for Tecartus® (brexucabtagene autoleucel) for the treatment of adult patients (18 years and older) with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
    Evidence Level:
    Sensitive: A2 - Guideline
    Source:
    NCCN
    Published date:
    12/16/2021
    Excerpt:
    PRINCIPLES OF SYSTEMIC THERAPY...PREGIMENS FOR RELAPSED Ph-NEGATIVE B-ALL...Other Recommended Regimens...Brexucabtagene autoleucel
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Kite Pharma Press Release
    Title:

    KITE'S TECARTUS® DEMONSTRATES HIGH RESPONSE RATE IN ADULTS WITH RELAPSED OR REFRACTORY B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA EARNING PRIORITY REVIEW DESIGNATION

    Published date:
    06/04/2021
    Excerpt:
    ...the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) and granted Priority Review designation for Tecartus for the treatment of adult patients with relapsed or refractory B-cell precursor ALL, with a target action date under the Prescription Drug User Fee Act (PDUFA) of October 1, 2021.