BeiGene Announces Swissmedic’s Approval of BRUKINSA (zanubrutinib) for the Treatment of Adult Patients with Waldenstrom’s Macroglobulinemia


BASEL, Switzerland & CAMBRIDGE, Mass. &BEIJING–(BUSINESS WIRE)–BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a science-driven global biotechnology company focused on developing innovative and affordable drugs, today announced that the BTK inhibitor of BeiGene BRUKINSA (zanubrutinib) has received approval from Swissmedic for the treatment of adult patients with Waldenstrom’s macroglobulinemia (WM) who have received at least one prior line of therapy, or for treatment-naïve patients who are not suitable for standard chemoimmunotherapy. BRUKINSA had previously obtained orphan drug status.

“The authorization of BRUKINSA will provide a new option and an innovative drug that has the potential to offer a deep and lasting response to eligible patients with WM in Switzerland”, said Prof. Davide Rossi, Deputy Head of the Division of hematology from the IOSI Institute of Oncology of Southern Switzerland: “BRUKINSA is a next-generation BTK inhibitor that has also shown significant improvements in tolerability for some WM patients compared to ibrutinib, because discontinuation of treatment remains a concern.

Reto Kessler, Country Manager, Switzerland at BeiGene added: “This approval is a significant development for people living with WM in Switzerland and for BeiGene’s expansion in Europe. Our teams are committed to working with the Federal Office of Public Health and healthcare professionals to ensure access to BRUKINSA for patients in Switzerland.

The Marketing Authorization Application (MA) is based on data from the global Phase 3 clinical trial ASPEN, a randomized, open-label, multicenter Phase 3 trial (NCT03053440) that evaluated BRUKINSA against the ibrutinib in patients with relapsed/refractory (R/R) or treatment-naïve (TN) WM who harbors a MYD88 mutation (MYD88MUT). In the ASPEN trial, BRUKINSA demonstrated a numerically higher very good partial response rate (VGPR) and a favorable safety profile compared to ibrutinib, although the primary endpoint of statistical superiority related to deep response (VGPR or better) has not been achieved. As assessed by the Independent Review Committee (IRC) by adaptation of the response criteria updated at the Sixth International Waldenström’s Macroglobulinemia (IWWM) Workshop, the combined complete response (CR) + VGPR rate in the The overall intention-to-treat (ITT) population was 29% with BRUKINSA (95% CI: 20, 40), compared to 19% with ibrutinib (95% CI: 12, 30).

In the ASPEN trial, of the 101 WM patients randomized and treated with BRUKINSA, four percent of patients discontinued due to adverse events, including cardiomegaly, neutropenia, plasma cell myeloma, and subdural hemorrhage. Adverse events leading to dose reduction occurred in 14% of patients, the most common being neutropenia (3%) and diarrhea (2%).

The recommended dose of BRUKINSA is 160 mg twice daily or 320 mg once daily, taken orally with or without food. The dose may be adjusted in case of adverse effects and reduced in patients with severe hepatic impairment and certain drug interactions.

About Waldenstrom’s Macroglobulinemia

WM is a rare B-cell lymphoma that occurs in less than two percent of patients with non-Hodgkin’s lymphoma.2 The disease usually affects older people and is mainly found in the bone marrow, although the lymph nodes and spleen may be involved.1 Across Europe, the estimated incidence rate of WM is around seven per million men and four per million women.2


BRUKINSA is a small molecule Bruton’s tyrosine kinase (BTK) inhibitor discovered by BeiGene scientists that is currently being evaluated globally in an extensive clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because novel BTK is continuously synthesized, BRUKINSA was specifically designed to provide complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been shown to inhibit malignant B cell proliferation in a number of disease-relevant tissues.

BRUKINSA is supported by an extensive clinical program that includes more than 3,900 subjects in 35 trials in 28 markets. To date, BRUKINSA has received more than 20 approvals covering more than 40 countries and regions, including the United States, European Union, China, Australia, Great Britain and Switzerland. Currently, more than 40 additional regulatory submissions are under review worldwide.

BeiGene Oncology

BeiGene is committed to advancing best-in-class and first-in-class clinical candidates internally or with like-minded partners to develop effective and affordable medicines for patients worldwide. We have a growing R&D and Medical Affairs team of approximately 2,900 colleagues dedicated to advancing more than 100 clinical trials that have involved more than 14,500 subjects. Our broad portfolio is primarily driven by our internal colleagues who support clinical trials in over 45 countries and regions. Hematology-oncology and targeted therapies for solid tumors and immuno-oncology are key focus areas for the Company, with monotherapies and combination therapies being priorities in our research and development. BeiGene currently has three approved drugs discovered and developed in our own labs: BTK Inhibitor BRUKINSA in the US, China, EU & UK, Canada, Australia and other international markets ; and tislelizumab, an anti-PD-1 antibody that binds to the non-FC-gamma receptor, as well as pamiparib, a PARP inhibitor, in China.

BeiGene also partners with innovative companies that share our goal of developing therapies to meet global health needs. We market a range of oncology drugs in China under license from Amgen, Bristol Myers Squibb, EUSA Pharma and Bio-Thera. We also plan to address larger areas of unmet need globally through our other collaborations, including with Mirati Therapeutics, Seagen and Zymeworks.

In January 2021, BeiGene and Novartis announced a collaboration granting Novartis the rights to co-develop, manufacture and commercialize BeiGene’s anti-PD1 antibody tislelizumab in North America, Europe and Japan. Building on this productive collaboration, including a Biologics License Application (BLA) pending FDA review, BeiGene and Novartis announced an Option, Collaboration and Licensing Agreement in December 2021 for the ociperlimab, a TIGIT inhibitor from BeiGene, which is in phase 3 development. Novartis and BeiGene have also entered into a strategic commercial agreement whereby BeiGene will promote five approved Novartis Oncology products in designated regions of China.

About BeiGene

BeiGene is a science-driven global biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. With a broad pipeline of over 40 clinical candidates, we are accelerating the development of our diverse portfolio of novel therapies through our own capabilities and collaborations. We are committed to radically improving access to medicines for two billion more people by 2030. BeiGene has a growing global team of over 8,000 colleagues across five continents. To learn more about BeiGene, please visit and follow us on Twitter at @BeiGeneGlobal.

Forward-looking statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BRUKINSA’s plans to develop and commercialize in Switzerland and elsewhere. other markets, plans to make BRUKINSA accessible to patients in Switzerland, BRUKINSA’s potential to provide enhanced clinical benefits to patients, and BeiGene’s plans, commitments, aspirations and goals under the headings “BeiGene Oncology” and “To About BeiGene”. Actual results may differ materially from those indicated in the forward-looking statements due to various important factors, including BeiGene’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results of its drug candidates, which may not warrant further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene’s ability to achieve commercial success for its marketed drugs and drug candidates, if approved; BeiGene’s ability to obtain and maintain intellectual property protection for its drugs and technology; BeiGene’s reliance on third parties to conduct drug development, manufacturing and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional financing for operations and to complete the development and commercialization of its drug candidates and to achieve and maintain profitability; the impact of the COVID-19 pandemic on BeiGene’s clinical development, regulatory, business and other operations, as well as the risks discussed in more detail in the section titled “Risk Factors” in BeiGene’s latest quarterly report on form 10-Q as well as discussions of potential risks, uncertainties and other important factors in BeiGene’s subsequent filings with the United States Securities and Exchange Commission. All information contained in this press release is as of the date of this press release, and BeiGene assumes no obligation to update such information except as required by law.

The references: Product information available on request from BeiGene Switzerland GmbH.

1 Lymphoma Research Foundation. Get the facts: Waldenström’s macroglobulinemia. Accessed July 2021. Available at

2 Buske, C, et al. Treatment and outcome patterns in European patients with Waldenström’s macroglobulinemia: a large retrospective observational chart review. The Lancet Hematology 2018; 5: e0299-309.


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