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

    BeiGene Announces Authorisation of BRUKINSA (zanubrutinib) from the United Kingdom’s MHRA for the Treatment of Adults with Waldenström’s Macroglobulinemia in Great Britain

    Published date:
    12/15/2021
    Excerpt:
    BeiGene...announced today that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has granted a marketing authorisation for BRUKINSA® (zanubrutinib) in Great Britain, for the treatment of eligible adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy or for the first-line treatment of eligible patients unsuitable for chemo-immunotherapy.
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    BeiGene Press Release
    Title:

    BeiGene Announces Approval of BRUKINSA (zanubrutinib) in the European Union for Treatment of Adults with Waldenström’s Macroglobulinemia

    Published date:
    11/23/2021
    Excerpt:
    BeiGene...announced today that the European Commission (EC) approved BRUKINSA® (zanubrutinib) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy or for the first-line treatment of patients unsuitable for chemo-immunotherapy.
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    BeiGene Press Release
    Title:

    BeiGene Announces China NMPA Approval of BRUKINSA® (Zanubrutinib) for the Treatment of Patients with Relapsed or Refractory Waldenström’s Macroglobulinemia

    Published date:
    06/18/2021
    Excerpt:
    BeiGene, Ltd....today announced that BRUKINSA® (zanubrutinib) has received conditional approval from the China National Medical Products Administration (NMPA) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy.
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    BeiGene Press Release
    Title:

    Health Canada Approves BRUKINSA (Zanubrutinib) for the Treatment of Waldenström’s Macroglobulinemia

    Published date:
    03/02/2021
    Excerpt:
    BeiGene...announced that BRUKINSA (zanubrutinib) has been approved by Health Canada for the treatment of adult patients with Waldenström’s macroglobulinemia (WM).
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    FDA
    Excerpt:
    BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with:...Waldenström’s macroglobulinemia (WM).
    Evidence Level:
    Sensitive: A2 - Guideline
    Source:
    BeiGene Press Release
    Title:

    NICE Recommends BeiGene’s BRUKINSA® (zanubrutinib) for Patients with Waldenström’s Macroglobulinemia who have had at Least One Treatment

    Published date:
    09/19/2022
    Excerpt:
    BeiGene...announced that England’s health technology assessment institute, the National Institute for Health and Care Excellence (NICE), has issued a final appraisal document (FAD) recommending BRUKINSA (zanubrutinib) for the treatment of Waldenström’s Macroglobulinemia (WM) in adults who have had at least one treatment, only if bendamustine plus rituximab is also suitable.
    Evidence Level:
    Sensitive: A2 - Guideline
    New
    Source:
    NCCN
    Excerpt:
    PRIMARY THERAPY FOR WM/LPL:Preferred Regimens...Zanubrutinib
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    BeiGene Press Release
    Title:

    BeiGene Announces Acceptance and Priority Review by Health Canada of New Drug Submission for BRUKINSA (zanubrutinib) in Waldenstrom’s Macroglobulinemia

    Published date:
    09/09/2020
    Excerpt:
    BeiGene...today announced that its New Drug Submission (NDS) for BRUKINSA (zanubrutinib) for the treatment of patients with Waldenström’s macroglobulinemia (WM) has been accepted by Health Canada and granted priority review status....Clinical data in the Canadian NDS include data from the Phase 3 randomized, open-label, multicenter ASPEN clinical trial (NCT03053440)...
    Evidence Level:
    Sensitive: B - Late Trials
    New
    Source:
    J Clin Oncol
    Title:

    Efficacy and safety of zanubrutinib versus rituximab-based chemoimmunotherapy in Waldenström macroglobulinemia (WM): Matching-adjusted indirect comparisons

    Excerpt:
    ...this study aimed to indirectly compare zanubrutinib with bendamustine-rituximab (BR) and with dexamethasone-rituximab-cyclophosphamide (DRC)...Zanubrutinib demonstrated longer PFS than DRC, and longer PFS and OS than BR in WM…
    DOI:
    10.1200/JCO.2021.39.15_suppl.7559
    Trial ID:
    ASPEN