On August 18, 2021 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, reported that Swissmedic has accepted the marketing authorization application (MAA) for BRUKINSA, a treatment option for adult patients with Waldenström’s macroglobulinaemia (WM) (Press release, BeiGene, AUG 18, 2021, View Source [SID1234586728]). Swissmedic has started the formal review of the MAA. BRUKINSA has already been granted orphan drug status by Swissmedic.
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"The acceptance of the marketing authorization application of BRUKINSA by Swissmedic is a crucial step in the development of BRUKINSA for Swiss patients with WM. We are looking forward to continuing our work with the health authorities to bring BRUKINSA to patients living with this rare, incurable blood cancer."
Swissmedic, the Swiss Agency for Therapeutic Products, reviews new products for market authorization. Within this process, Swissmedic evaluates a product’s quality, safety, and effectiveness through clinical trial data.
Gerwin Winter, Senior Vice President, Head of Commercial, Europe, at BeiGene said: "The acceptance of the marketing authorization application of BRUKINSA by Swissmedic is a crucial step in the development of BRUKINSA for Swiss patients with WM. We are looking forward to continuing our work with the health authorities to bring BRUKINSA to patients living with this rare, incurable blood cancer."
The MAA is supported by data from the randomized Phase 3 ASPEN clinical trial (NCT03734016), evaluating zanubrutinib compared to ibrutinib in adult patients with WM.1
The approval by Swissmedic would grant marketing authorization for BRUKINSA in WM within Switzerland.
About Waldenström’s Macroglobulinemia
WM is a rare lymphoma representing approximately 1% of all non-Hodgkin lymphomas and typically progresses slowly after diagnosis.2 The disease usually affects older adults and is primarily found in the bone marrow, although lymph nodes and the spleen may be involved.3 Throughout Europe, the estimated incidence rate of WM is approximately 7 for every 1 million men and 4 for every 1 million women.4
About BRUKINSA (zanubrutinib)
BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver 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 demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.
BRUKINSA is currently approved in several regions for various indications.1 To date, more than 30 marketing authorization applications in multiple indications have been submitted covering the United States, the European Union, and more than 20 other countries or regions.