Brukinsa FDA Approval History
Last updated by Judith Stewart, BPharm on June 13, 2025.
FDA Approved: Yes (First approved November 14, 2019)
Brand name: Brukinsa
Generic name: zanubrutinib
Dosage form: Capsules and Tablets
Company: BeOne Medicines USA, Inc.
Treatment for: Mantle Cell Lymphoma, Waldenström Macroglobulinemia, Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma, Follicular Lymphoma
Brukinsa (zanubrutinib) is a Bruton’s tyrosine kinase (BTK) inhibitor used for the treatment of mantle cell lymphoma, Waldenström’s macroglobulinemia, marginal zone lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma, and follicular lymphoma.
- Brukinsa is indicated for the treatment of adult patients with:
- Mantle cell lymphoma (MCL) who have received at least one prior therapy.
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.
- Waldenström’s macroglobulinemia (WM).
- Marginal zone lymphoma (MZL) (relapsed or refractory) who have received at least one anti-CD20-based regimen.
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.
- Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
- Follicular Lymphoma (FL) (relapsed or refractory) in combination with obinutuzumab, after two or more lines of systemic therapy.
This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. - Brukinsa capsules and tablets 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 upper respiratory tract infection, hemorrhage, and musculoskeletal pain.
Common laboratory abnormalities include decreased neutrophil count, and decreased platelet count.
Development timeline for Brukinsa
Further information
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