Names
Brukinsa® ZanubrutinibIndications and usage
Zanubrutinib 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)
- 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 (CLL) or small lymphocytic lymphoma (SLL).
- 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.
Side effects needing medical attention
The most common adverse reactions included neutrophil count decreased, platelet count decreased, upper respiratory tract infection, white blood cell count decreased, hemoglobin decreased, rash, bruising, diarrhea and cough.