BRUKINSA zanubrutinib

Drug Class

Bruton's tyrosine kinase inhibitor

Mechanism

Covalently binds and inhibits Bruton's tyrosine kinase (BTK), blocking B-cell antigen receptor signaling and preventing lymphoma cell growth.

Approved Indication

Treatment of adult patients with mantle cell lymphoma (MCL), Waldenström's macroglobulinemia (WM), marginal zone lymphoma (MZL), chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

What This Means For Patients

Brukinsa (zanubrutinib) is a highly selective BTK inhibitor used to treat chronic lymphocytic leukemia and various B-cell lymphomas. It functions by disabling the BTK protein to stop the proliferation of malignant B-cells. It is available under the special-import policy in the Hainan Boao Lecheng pilot zone.

Regulatory Approvals

• FDA — approved (2019) — label
• NMPA — approved (2020) — source
• EMA — approved (2021) — source

Pivotal Clinical Evidence

• ALPINE — Brown et al., N Engl J Med 2023 (NCT03734016) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213217s015lbl.pdf
• https://www.nmpa.gov.cn/
• https://www.ema.europa.eu/en/medicines/human/EPAR/brukinsa