FDA label
What is Brukinsa used for?
Brukinsa contains zanubrutinib. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for Brukinsa lists 5 uses: Mantle Cell Lymphoma; Waldenström's Macroglobulinemia; Marginal Zone Lymphoma; Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma; and 1 more.
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Brukinsa, capsule
Indications and Usage, quoted from the label by BeOne Medicines USA, Inc. (NDA213217). Cross-references to other label sections are left out.
Mantle Cell 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
BRUKINSA is indicated for the treatment of adult patients with Waldenström's macroglobulinemia (WM).
Marginal Zone Lymphoma
BRUKINSA is indicated for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) 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 or Small Lymphocytic Lymphoma
BRUKINSA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Follicular Lymphoma
BRUKINSA is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL), 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.
Source: DailyMed label, set id 3e08fe23-d70e-424c-bc51-1222e320f902, version 25, effective September 4, 2026. NDC 72579-011, one of 1 listing for this product.
Questions
What is Brukinsa used for?
The FDA label for Brukinsa lists 5 uses: Mantle Cell Lymphoma; Waldenström's Macroglobulinemia; Marginal Zone Lymphoma; Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma; and 1 more.
What drug class is Brukinsa?
FDA lists zanubrutinib in the Kinase Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.