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
Further information
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