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Brukinsa FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 24, 2023.

FDA Approved: Yes (First approved November 14, 2019)
Brand name: Brukinsa
Generic name: zanubrutinib
Dosage form: Capsules
Company: BeiGene, Ltd.
Treatment for: Mantle Cell Lymphoma, Waldenström Macroglobulinemia, Lymphoma, Chronic Lymphocytic Leukemia

Brukinsa (zanubrutinib) is a Bruton’s tyrosine kinase (BTK) inhibitor used for the treatment of mantle cell lymphoma (MCL), Waldenström’s macroglobulinemia (WM), marginal zone lymphoma (MZL), and chronic lymphocytic leukemia or small lymphocytic lymphoma (SLL).

  • Brukinsa is indicated for the treatment of adult patients with:
    • Mantle cell lymphoma* (MCL) who have received at least one prior therapy.
    • Waldenström’s macroglobulinemia (WM).
    • Marginal zone lymphoma* (MZL) (relapsed or refractory) who have received at least one anti-CD20-based regimen.
    • Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
  • Brukinsa capsules are administered orally at a dosage of 160 mg twice daily, or 320 mg once daily.
  • Warnings and precautions associated with Brukinsa include hemorrhage, infections, cytopenias, second primary malignancies including skin cancers, cardiac arrhythmias, and embryo-fetal toxicity.
  • Common adverse reactions include decreased neutrophil count, upper respiratory tract infection, decreased platelet count, hemorrhage, and musculoskeletal pain.

*This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Development timeline for Brukinsa

Jan 19, 2023Approval Brukinsa (zanubrutinib) Approved in the U.S. for Chronic Lymphocytic Leukemia
Sep 15, 2021Approval U.S. FDA Grants Brukinsa (zanubrutinib) Accelerated Approval in Relapsed or Refractory Marginal Zone Lymphoma
Sep  1, 2021Approval U.S. FDA Grants Brukinsa (zanubrutinib) Approval in Waldenström’s Macroglobulinemia
Nov 14, 2019Approval FDA Approves Brukinsa (zanubrutinib) for the Treatment of Mantle Cell Lymphoma
Aug 21, 2019BeiGene Announces U.S. FDA Acceptance and Grant of Priority Review for its New Drug Application of Zanubrutinib in Patients with Relapsed/Refractory Mantle Cell Lymphoma
Dec  1, 2018BeiGene Announces Clinical Results of Zanubrutinib in Mantle Cell Lymphoma From Two Presentations at the 60th American Society of Hematology Annual Meeting

Further information

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