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    Association details:
    Biomarker:CD20 positive
    Cancer:Chronic Lymphocytic Leukemia
    Drug:Gazyva (obinutuzumab) (CD20 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    Chugai Press Release
    Title:

    Humanized Anti-CD20 Monoclonal Antibody Gazyva Approved for Additional Indication of Chronic Lymphocytic Leukemia

    Published date:
    12/23/2022
    Excerpt:
    Chugai Pharmaceutical Co., Ltd....and Nippon Shinyaku Co., Ltd....announced that Chugai obtained regulatory approval today from the Ministry of Health, Labour and Welfare (MHLW) for an anti-cancer agent/humanized anti-CD20 monoclonal antibody Gazyva® Intravenous Infusion 1000 mg [generic name: obinutuzumab (genetical recombination)] for an additional indication of CD20-positive chronic lymphocytic leukemia (including small lymphocytic lymphoma)....The approval is based on data including the phase III ELEVATE-TN study...
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    FDA
    Excerpt:
    GAZYVA (obinutuzumab) is a CD20-directed cytolytic antibody and is indicated, in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia.
    Secondary therapy:
    chlorambucil
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of Obinutuzumab (GA101; RO5072759) in Combination With Chemotherapy in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL) (GALTON)

    Excerpt:
    ...- Confirmed diagnosis of CD20-positive B-CLL...
    Trial ID:
    GALTON
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study Comparing Obinutuzumab (RO5072759; GA101) 1000 Milligram (mg) Versus 2000 mg in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL) (GAGE)

    Excerpt:
    ...- Confirmed diagnosis of CD20-positive B-cell CLL (per International Workshop on Chronic Lymphocytic Leukemia [IWCLL] guidelines)...
    Trial ID:
    NCT01414205
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    An Expanded Access, Open-Label Study of Obinutuzumab (GA101) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia

    Excerpt:
    ...- Confirmed diagnosis of CD20-positive CLL (per IWCLL guidelines, Hallek et al 2008)...
    Trial ID:
    NCT01868893