BeiGene, a global biotechnology company, has received approval from Swissmedic for its BTK inhibitor, BRUKINSA (zanubrutinib), for the treatment of adult patients with Waldenström’s macroglobulinemia (WM). This approval is significant for patients who have received at least one prior line of therapy or for those who are treatment-naïve and not suited for standard chemo-immunotherapy. BRUKINSA, which had previously been granted orphan drug status, is now approved in 44 markets, including the EU, US, and Great Britain.
The approval is based on data from the global Phase 3 ASPEN clinical trial, which compared BRUKINSA to ibrutinib in patients with relapsed/refractory or treatment-naïve WM who harbor a MYD88 mutation. The trial demonstrated that BRUKINSA had a numerically higher very good partial response (VGPR) rate and a favorable safety profile over ibrutinib, although it did not meet the primary endpoint of statistical superiority related to deep response (VGPR or better).
In the ASPEN trial, adverse events leading to treatment discontinuation occurred in four percent of patients treated with BRUKINSA, with the most common being neutropenia and diarrhea. The recommended dose of BRUKINSA is either 160 mg twice daily or 320 mg once daily, with adjustments possible for adverse reactions and for patients with severe hepatic impairment.
Waldenström’s macroglobulinemia is a rare B-cell lymphoma affecting less than two percent of patients with non-Hodgkin lymphomas, primarily older adults. BRUKINSA, a small molecule inhibitor of Bruton’s tyrosine kinase (BTK), is part of a broad clinical program that includes more than 3,900 subjects in 35 trials across 28 markets. It has received over 20 approvals covering more than 40 countries and regions.
BeiGene is committed to advancing innovative and affordable medicines, with a focus on hematology-oncology and solid tumor targeted therapies. The company has a growing R&D and medical affairs team dedicated to advancing more than 100 clinical trials involving over 14,500 subjects. BeiGene's portfolio includes three approved medicines discovered and developed in its own labs, including BRUKINSA, and it collaborates with other companies to develop therapies addressing global health needs.
