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

Further information

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