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

    BRUKINSA Approved in Canada for the Treatment of Chronic Lymphocytic Leukemia

    Published date:
    05/30/2023
    Excerpt:
    BeiGene, Ltd...announced today that BRUKINSA (zanubrutinib), a Bruton's tyrosine kinase inhibitor (BTKi), has been approved by Health Canada for the treatment of adult patients with chronic lymphocytic leukemia (CLL).
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    BeiGene Press Release
    Title:

    BeiGene Receives European Commission Approval for BRUKINSA® (zanubrutinib) for the Treatment of Adults with Chronic Lymphocytic Leukemia (CLL)

    Published date:
    11/17/2022
    Excerpt:
    BeiGene...today announced that the European Commission (EC) has approved BRUKINSA® (zanubrutinib) for the treatment of adult patients with treatment-naïve (TN) or relapsed/refractory (R/R) CLL….The EC approval is based on positive results from two Phase 3 clinical trials: SEQUOIA (NCT03336333), in patients with previously untreated CLL, and ALPINE (NCT03734016), in patients with R/R CLL.
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    BeiGene Press Release
    Title:

    BeiGene Announces the Approval of BRUKINSA (Zanubrutinib) in China for Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma and Relapsed/Refractory Mantle Cell Lymphoma

    Published date:
    06/03/2020
    Excerpt:
    BeiGene, Ltd....today announced that its BTK inhibitor BRUKINSA (zanubrutinib) has received approval from the China National Medical Products Administration (NMPA) in two indications – the treatment of adult patients with chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL) who have received at least one prior therapy, and the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    FDA
    Excerpt:
    BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with:...Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
    Evidence Level:
    Sensitive: A2 - Guideline
    Source:
    BeiGene Press Release
    Title:

    BRUKINSA® Receives Positive Recommendation from NICE in U.K. for Adult Patients with Chronic Lymphocytic Leukemia

    Published date:
    10/20/2023
    Excerpt:
    BeiGene, Ltd...announced the National Institute for Health and Care Excellence (NICE) of the United Kingdom (U.K.) has issued a final draft guidance (FDG) recommending BRUKINSA® (zanubrutinib) for the treatment of eligible adult patients with...Untreated chronic lymphocytic leukemia (CLL) if there is a 17p deletion or TP53 mutation (high risk) or...Relapsed or refractory CLL.
    Evidence Level:
    Sensitive: A2 - Guideline
    Source:
    NCCN
    Published date:
    06/03/2022
    Excerpt:
    Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma...SUGGESTED TREATMENT REGIMENS...CLL/SLL without del(17p)/TP53 mutation...Preferred regimens...Zanubrutinib…
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    N Engl J Med
    Title:

    Zanubrutinib or Ibrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia

    Published date:
    01/26/2023
    Excerpt:
    In patients with relapsed or refractory CLL or SLL, progression-free survival was significantly longer among patients who received zanubrutinib than among those who received ibrutinib, and zanubrutinib was associated with fewer cardiac adverse events.
    DOI:
    10.1056/NEJMoa2211582
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Lancet Oncol
    Title:

    Zanubrutinib versus bendamustine and rituximab in untreated chronic lymphocytic leukaemia and small lymphocytic lymphoma (SEQUOIA): a randomised, controlled, phase 3 trial

    Published date:
    07/07/2022
    Excerpt:
    We compared zanubrutinib with bendamustine–rituximab to determine its effectiveness as frontline therapy in patients with CLL or SLL....Progression-free survival was significantly improved in group A versus group B (HR 0·42 [95% CI 0·28 to 0·63]; two-sided p<0·0001)....Zanubrutinib significantly improved progression-free survival versus bendamustine–rituximab, with an acceptable safety profile consistent with previous studies.
    DOI:
    10.1016/S1470-2045(22)00293-5
    Trial ID:
    SEQUOIA
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    BeiGene Press Release
    Title:

    BeiGene Announces Positive Topline Results from Phase 3 SEQUOIA Trial Comparing BRUKINSA® (Zanubrutinib) to Bendamustine Plus Rituximab in Patients with Treatment-Naïve Chronic Lymphocytic Leukemia

    Published date:
    07/29/2021
    Excerpt:
    BeiGene...announced positive topline results from an interim analysis of the Phase 3 SEQUOIA trial comparing BRUKINSA (zanubrutinib) to bendamustine and rituximab (B+R) in patients with treatment-naive (TN) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)...BRUKINSA achieved a highly statistically significant improvement in PFS compared to B+R.
    Trial ID:
    SEQUOIA
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    BeiGene Press Release
    Title:

    BRUKINSA (Zanubrutinib) Demonstrates Superior Objective Response Rate by Investigator Assessment and Reduced Rates of Atrial Fibrillation or Flutter at Interim Analysis in Head-to-Head Trial Against Ibrutinib in Chronic Lymphocytic Leukemia

    Published date:
    04/28/2021
    Excerpt:
    BeiGene...announced positive results from a planned interim analysis of the Phase 3 ALPINE trial comparing BRUKINSA (zanubrutinib) against ibrutinib in adults with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)...BRUKINSA met the primary endpoint of the trial, demonstrating non-inferiority in objective response rate (ORR)...