Brukinsa FDA Approval History
Reviewed by J.Stewart BPharm. Last updated on Nov 19, 2019.
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
Brukinsa (zanubrutinib) is a Bruton’s tyrosine kinase (BTK) inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
- Brukinsa was granted accelerated approval from the FDA based on overall response rate (ORR), and further clinical trials may be required to describe and verify the clinical benefits.
- The approval of Brukinsa was based on efficacy results from two single-arm clinical trials, with ORR as the primary endpoint. Across both trials, 84% of patients treated with Brukinsa achieved complete or partial shrinkage of their tumors.
- Brukinsa capsules are taken orally at a dosage of 160 mg twice daily, or 320 mg once daily. The capsules should be swallowed whole with water and can be taken with or without food.
- Patients taking Brukinsa should be monitored for signs of hemorrhage, infections, cytopenias, second primary malignancies including skin cancers, and cardiac arrhythmias. Brukinsa can cause harm to a developing fetus, and women of childbearing potential should use effective contraception.
- Common adverse reactions include decreased neutrophil count, decreased platelet count, upper respiratory tract infection, decreased white blood cell count, decreased hemoglobin, rash, bruising, diarrhea, and cough.
Development Timeline for Brukinsa
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