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 is not distributed through mainland China's retail pharmacy network. Uwell Cloud can help arrange a purchase channel for this medicine, sourced and dispatched from Hong Kong; clinical administration support in China can be coordinated on request. Availability and eligibility for any specific patient are determined by clinical review.

Regulatory Approvals

• FDA — Approved (2019) — Sources
• NMPA — Approved (2020) — Sources
• EMA — Approved (2021) — Sources

Pivotal Clinical Evidence

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

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