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Brukinsa FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 16, 2021.

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’s Macroglobulinemia; Marginal Zone Lymphoma

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

  • 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.
  • Brukinsa capsules are administered orally at a dosage of 160 mg twice daily, or 320 mg once daily.
  • Brukinsa can cause serious adverse reactions including hemorrhage, infections, cytopenias, second primary malignancies including skin cancers, cardiac arrhythmias, and embryo-fetal toxicity.
  • Common adverse reactions include neutrophil count decreased, upper respiratory tract infection, platelet count decreased, rash, hemorrhage, musculoskeletal pain, hemoglobin decreased, bruising, diarrhea, pneumonia, and cough.
  1. *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

DateArticle
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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