Drug updated on 4/18/2024
| Dosage Form | Capsule (oral; 80 mg) |
| Drug Class | Kinase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
- Indicated for the treatment of adult patients with Waldenström’s macroglobulinemia (WM).
- 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.
- Indicated for the treatment of adult patients with Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Summary
- Zanubrutinib (Brukinsa) is indicated for the treatment of adult patients with mantle cell lymphoma, Waldenström’s macroglobulinemia, marginal zone lymphoma, and chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least one prior therapy.
- Three systematic reviews/meta-analyses were examined to gather information about this drug.
- In terms of effectiveness, zanubrutinib showed high Overall Response Rates across studies, and its 24-month overall survival/progression-free survival rates were higher compared to acalabrutinib monotherapy.
- Regarding the safety profile, zanubrutinib had a lower incidence of total serious adverse reactions compared to other Bruton's tyrosine kinase inhibitors like ibrutinib, which showed higher adverse reactions. Common Adverse Events such as diarrhea, hypertension, and cardiac events occurred less frequently in patients treated with zanubrutinib than those treated with other drugs in the same class.
- Subgroup considerations revealed that new-generation BTKi-based therapy including zanubrutinib demonstrated superior efficacy under treatment conditions in patients below 65 years old, particularly in treatment-naïve individuals. The outcomes, however, diminished for those who had multiple prior lines of therapy.
- Despite these promising results from meta-analysis data on Brukinsa (zanubrutinib), it was suggested that fully randomized-controlled trials are still necessary to make more definitive conclusions, especially considering the relatively high adverse event rates associated with combination therapies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Brukinsa (zanubrutinib) Prescribing Information. | 2023 | BeiGene USA, Inc., San Mateo, CA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Evaluation of Bruton tyrosine kinase inhibitors monotherapy and combination therapy in lymphocytic leukemia. | 2024 | Clinical and Experimental Medicine |
| Efficacy and safety of new-generation Bruton tyrosine kinase inhibitors in chronic lymphocytic leukemia/small lymphocytic lymphoma: a systematic review and meta-analysis. | 2023 | Annals of Hematology |
| Zanubrutinib monotherapy for naïve and relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma: a pooled analysis of three studies. | 2022 | Advances in Therapy |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Consensus treatment recommendations from the tenth international workshop for Waldenström macroglobulinaemia. | 2020 | Lancet Haemotology |