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    Association details:
    Biomarker:No biomarker
    Cancer:Marginal Zone Lymphoma
    Drug:Brukinsa (zanubrutinib) (BTK inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    BeiGene Press Release
    Title:

    BeiGene Receives European Commission Approval for BRUKINSA® (zanubrutinib) for the Treatment of Adults with Marginal Zone Lymphoma

    Published date:
    11/02/2022
    Excerpt:
    BeiGene...a global biotechnology company, today announced that the European Commission (EC) has granted marketing authorization of BRUKINSA® (zanubrutinib) for the treatment of adult patients with relapsed/refractory (R/R) marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy. The approval is applicable to all 27 member states of the European Union (EU), plus Iceland and Norway.
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    FDA
    Excerpt:
    BRUKINSA 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 anti-CD20-based regimen.
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    BeiGene Press Release
    Title:

    BeiGene Announces U.S. FDA Acceptance and Priority Review of Supplemental New Drug Application for BRUKINSA (Zanubrutinib) in Marginal Zone Lymphoma

    Published date:
    05/19/2021
    Excerpt:
    BeiGene, Ltd...announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental new drug application (sNDA) for BRUKINSA (zanubrutinib) for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy and granted priority review.