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    Association details:
    Biomarker:No biomarker
    Cancer:Marginal Zone Lymphoma
    Drug:Ukoniq (umbralisib) (PI3Kδ inhibitor, Casein kinase I epsilon inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    FDA
    Published date:
    02/05/2021
    Excerpt:
    UKONIQ is a kinase inhibitor indicated for the treatment of adult patients with...Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen.
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    GlobeNewswire
    Title:

    TG Therapeutics Announces FDA Acceptance of New Drug Application for Umbralisib as a Treatment for Patients with Previously Treated Marginal Zone Lymphoma and Follicular Lymphoma

    Published date:
    08/13/2020
    Excerpt:
    TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for umbralisib, the Company’s investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with previously treated marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen and follicular lymphoma (FL) who have received at least two prior systemic therapies.