{"id":24279,"date":"2021-04-08T17:41:00","date_gmt":"2021-04-08T17:41:00","guid":{"rendered":"https:\/\/beonemedicines.ca\/fr\/?post_type=pressreleases&#038;p=24176"},"modified":"2025-12-04T20:11:21","modified_gmt":"2025-12-04T20:11:21","slug":"beigene-launches-brukinsa-for-waldenstroms-in-canada","status":"publish","type":"pressreleases","link":"https:\/\/beonemedicines.ca\/en\/pressreleases\/beigene-launches-brukinsa-for-waldenstroms-in-canada\/","title":{"rendered":"BeiGene Launches BRUKINSA\u00ae (Zanubrutinib) in Canada for Patients with Waldenstr\u00f6m\u2019s Macroglobulinemia"},"content":{"rendered":"<style> .nav-tertiary-sec.custom-spacing { padding-top: 50px ; } <\/style><style> .nav-tertiary-sec.custom-spacing { position:relative; z-index:3; } <\/style><!-- Copy block -->\r\n<section class=\"nav-tertiary-sec copy-block  custom-spacing  bg-white\" >\r\n    <div class=\"container\">\r\n        <div class=\"row\">\r\n            \r\n            <div class=\"col-md-8 col-lg-9\">\r\n                \r\n                <div class=\"main-container tab-container\">                    \r\n                                                <section class=\"section anim fadeInUp \">\r\n                            <!-- <section class=\"section anim fadeInUp \" > -->\r\n                                <div class=\"sec-header\">\r\n                                    <div class=\"sec-head\">\r\n                                                                                                                    <\/div>\r\n                                    <div class=\"sec-body\">\r\n                                                                                    \r\n                                            <div><ul>\n<li><em>BRUKINSA is now commercially available in\u00a0Canada\u00a0following approval in March.<\/em><\/li>\n<li><em>Canadian patients now have access to the myBeiGene<sup>\u00ae<\/sup> patient support program.<\/em><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>MISSISSAUGA, Ontario&#8211;(BUSINESS WIRE)&#8211;\u00a0BeiGene, Ltd.\u00a0(NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced the official launch of BRUKINSA<sup>\u00ae<\/sup>\u00a0(zanubrutinib) in\u00a0Canada\u00a0for the treatment of adult patients with Waldenstr\u00f6m\u2019s macroglobulinemia (WM). BRUKINSA was authorized for sale by\u00a0Health Canada\u00a0in this indication on\u00a0March 1, 2021, following the previous grant of priority review in\u00a0September 2020.<\/p>\n<p><!-- wp:paragraph --><\/p>\n<p>In tandem with the commercial launch of BRUKINSA, the myBeiGene<sup>\u00ae<\/sup>\u00a0patient support program is available in\u00a0Canada\u00a0to support patients, caregivers, and healthcare providers with access to BRUKINSA.<\/p>\n<p><!-- \/wp:paragraph --> <!-- wp:paragraph --><\/p>\n<p>\u201cWe are thrilled to officially launch BRUKINSA in\u00a0Canada, making this potentially best-in-class BTK inhibitor available to Canadian WM patients. Since the approval in\u00a0Canada\u00a0five weeks ago, our team has been working to set up distribution channels across the country for a speedy launch,\u201d said\u00a0Peter Brenders, General Manager of\u00a0Canada\u00a0at\u00a0BeiGene. \u201cTogether with the myBeiGene patient support program with comprehensive financial assistance, disease education, and emotional support, we are striving to ensure access for patients in Canada.\u201d<\/p>\n<p><!-- \/wp:paragraph --> <!-- wp:paragraph --><\/p>\n<p>\u201cOn behalf of the Waldenstr\u00f6m\u2019s\u00a0Macroglobulinemia Foundation of Canada\u00a0(WMFC), we are pleased to see BeiGene\u2019s launch of BRUKINSA as a WM treatment in\u00a0Canada\u00a0following the approval last month. We hope this will help expand access to an important treatment option for Canadian WM patients,&#8221; commented\u00a0Paul Kitchen, Chair of the Board at WMFC.<\/p>\n<p><!-- \/wp:paragraph --> <!-- wp:paragraph --><\/p>\n<p>The approval in\u00a0Canada\u00a0for BRUKINSA was based on efficacy results from the Phase 3 ASPEN clinical trial, a randomized, open-label, multicenter trial (NCT03053440) that evaluated BRUKINSA compared to ibrutinib in patients with relapsed\/refractory (R\/R) or treatment-na\u00efve (TN) WM who harbor a MYD88 mutation (<em>MYD88<sup>MUT<\/sup><\/em>). In the\u00a0ASPEN\u00a0trial, BRUKINSA demonstrated a numerically higher very good partial response (VGPR) rate and a favorable safety profile over ibrutinib, although the primary endpoint of statistical superiority related to deep response (VGPR or better) was not met.<\/p>\n<p><!-- \/wp:paragraph --> <!-- wp:paragraph --><\/p>\n<p>The overall safety profile of BRUKINSA is based on pooled data from 779 patients with B-cell malignancies treated with BRUKINSA in clinical trials.<\/p>\n<p><!-- \/wp:paragraph --> <!-- wp:paragraph --><\/p>\n<p>The recommended total daily dose of BRUKINSA is 320mg.<\/p>\n<p><!-- \/wp:paragraph --> <!-- wp:paragraph --><\/p>\n<p>\u201cZanubrutinib is a newly approved treatment in\u00a0Canada. We are glad to learn that this second-generation BTK inhibitor is now available for Canadian patients,\u201d said\u00a0Christine Chen, M.D., Med, FRCPC, Associate Professor at the\u00a0University of Toronto\u00a0and Clinical Investigator at\u00a0Princess Margaret Cancer Centre.<\/p>\n<p><!-- \/wp:paragraph --> <!-- wp:paragraph --><\/p>\n<p><strong>About myBeiGene<sup>\u00ae<\/sup>\u00a0Patient Support Program<\/strong><\/p>\n<p><!-- \/wp:paragraph --> <!-- wp:paragraph --><\/p>\n<p>The myBeiGene<sup>\u00ae<\/sup>\u00a0patient support program is designed to support patients, caregivers, and healthcare providers with access to BRUKINSA<sup>\u00ae<\/sup>. It goes beyond financial assistance support to provide patients and caregivers with education about their disease and treatment with BRUKINSA, as well provide practical and emotional support by connecting them to third-party resources that can address their individual needs. Oncology Nurse Advocates are available Monday through Friday from\u00a08 a.m. to 5 p.m. Eastern Time\u00a0at 1-833-234-4366.<\/p>\n<p><!-- \/wp:paragraph --> <!-- wp:paragraph --><\/p>\n<p><strong>About Waldenstr\u00f6m\u2019s Macroglobulinemia<\/strong><\/p>\n<p><!-- \/wp:paragraph --> <!-- wp:paragraph --><\/p>\n<p>Waldenstr\u00f6m\u2019s macroglobulinemia(WM) is a rare indolent B-cell lymphoma that occurs in less than two percent of patients with non-Hodgkin\u2019s lymphoma (NHL). The disease usually affects older adults and is primarily found in the bone marrow, although lymph nodes and the spleen may be involved.<sup>1<\/sup>\u00a0In\u00a0Canada\u00a0and\u00a0the United States, the incidence rate of WM is about five cases per million people per year.<sup>2<\/sup><\/p>\n<p><!-- \/wp:paragraph --> <!-- wp:paragraph --><\/p>\n<p><strong>About BRUKINSA<sup>\u00ae<\/sup>\u00a0(zanubrutinib)<\/strong><\/p>\n<p><!-- \/wp:paragraph --> <!-- wp:paragraph --><\/p>\n<p>BRUKINSA (zanubrutinib) is a small molecule inhibitor of Bruton\u2019s tyrosine kinase (BTK), discovered by\u00a0BeiGene\u00a0scientists, that is currently being evaluated globally in a broad pivotal clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies.<\/p>\n<p><!-- \/wp:paragraph --> <!-- wp:paragraph --><\/p>\n<p>BRUKINSA is approved in the following indications and regions:<\/p>\n<p><!-- \/wp:paragraph --> <!-- wp:list --><\/p>\n<ul class=\"wp-block-list\">\n<li style=\"list-style-type: none;\">\n<ul class=\"wp-block-list\"><!-- wp:list-item --><\/p>\n<li>For the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy (United States,\u00a0November 2019)*;<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><!-- \/wp:list-item --> <!-- wp:list-item --><\/p>\n<ul class=\"wp-block-list\">\n<li style=\"list-style-type: none;\">\n<ul class=\"wp-block-list\">\n<li>For the treatment of MCL in adult patients who have received at least one prior therapy (China,\u00a0June 2020)**;<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><!-- \/wp:list-item --> <!-- wp:list-item --><\/p>\n<ul class=\"wp-block-list\">\n<li style=\"list-style-type: none;\">\n<ul class=\"wp-block-list\">\n<li>For the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL\/SLL) in adult patients who have received at least one prior therapy (China,\u00a0June 2020)**;<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><!-- \/wp:list-item --> <!-- wp:list-item --><\/p>\n<ul class=\"wp-block-list\">\n<li style=\"list-style-type: none;\">\n<ul class=\"wp-block-list\">\n<li>For the treatment of relapsed or refractory MCL (United Arab Emirates,\u00a0February 2021); and<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><!-- \/wp:list-item --> <!-- wp:list-item --><\/p>\n<ul class=\"wp-block-list\">\n<li style=\"list-style-type: none;\">\n<ul class=\"wp-block-list\">\n<li>For the treatment of Waldenstr\u00f6m\u2019s macroglobulinemia (WM) in adult patients (Canada,\u00a0March 2021).<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><!-- \/wp:list-item --><\/p>\n<p><!-- \/wp:list --> <!-- wp:paragraph --><\/p>\n<p>In\u00a0Canada, a new drug submission for BRUKINSA for the treatment of patients with MCL who have received at least one prior therapy has been accepted and is currently under review. Currently, more than 20 marketing applications for BRUKINSA have been submitted, covering more than 40 countries and regions globally, including\u00a0the United States,\u00a0China, and\u00a0European Union.<\/p>\n<p><!-- \/wp:paragraph --> <!-- wp:table {\"hasFixedLayout\":false} --><\/p>\n<figure class=\"wp-block-table\">\n<table>\n<tbody>\n<tr>\n<td>* This indication was approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.<\/td>\n<\/tr>\n<tr>\n<td>** This indication was approved under conditional approval. Complete approval for this indication may be contingent upon results from one or more ongoing randomized, controlled confirmatory clinical trials.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/figure>\n<p><!-- \/wp:table --> <!-- wp:paragraph --><\/p>\n<p><strong>About BeiGene<\/strong><\/p>\n<p><!-- \/wp:paragraph --> <!-- wp:paragraph --><\/p>\n<p>BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents. To learn more about BeiGene, please visit\u00a0<a href=\"https:\/\/www.beigene.com\/\" target=\"_blank\" rel=\"noreferrer noopener\">www.beigene.com<\/a>\u00a0and follow us on\u00a0LinkedIn,\u00a0X\u00a0(formerly known as Twitter) and\u00a0<a href=\"https:\/\/www.facebook.com\/BeiGeneGlobal\/\" target=\"_blank\" rel=\"noreferrer noopener\">Facebook<\/a>.<\/p>\n<p><!-- \/wp:paragraph --> <!-- wp:paragraph --><\/p>\n<p><strong>Forward-Looking Statements<\/strong><\/p>\n<p><!-- \/wp:paragraph --> <!-- wp:paragraph --><\/p>\n<p>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 plans for setting up distribution channels in\u00a0Canada\u00a0for the commercialization of BRUKINSA, the potential for BRUKINSA to be a best-in-class BTK inhibitor and plans for making BRUKINSA accessible to patients, caregivers, and healthcare providers in\u00a0Canada. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including\u00a0BeiGene&#8217;s\u00a0ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval;\u00a0BeiGene&#8217;s\u00a0ability to achieve commercial success for its marketed medicines and drug candidates, if approved;\u00a0BeiGene&#8217;s\u00a0ability to obtain and maintain protection of intellectual property for its medicines and technology;\u00a0BeiGene&#8217;s\u00a0reliance on third parties to conduct drug development, manufacturing and other services; BeiGene\u2019s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; the impact of the COVID-19 pandemic on BeiGene\u2019s clinical development, regulatory, commercial, and other operations, as well as those risks more fully discussed in the section entitled \u201cRisk Factors\u201d in BeiGene\u2019s most recent annual report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in\u00a0BeiGene&#8217;s\u00a0subsequent filings with the\u00a0U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and\u00a0BeiGene\u00a0undertakes no duty to update such information unless required by law.<\/p>\n<p><!-- \/wp:paragraph --> <!-- wp:table {\"hasFixedLayout\":false} --><\/p>\n<figure class=\"wp-block-table\">\n<table>\n<tbody>\n<tr>\n<td><sup>1<\/sup>\u00a0Lymphoma Research Foundation. Available at\u00a0<a href=\"https:\/\/lymphoma.org\/aboutlymphoma\/nhl\/wm\/\">https:\/\/lymphoma.org\/aboutlymphoma\/nhl\/wm\/<\/a>. Accessed\u00a0December 2020.<\/td>\n<\/tr>\n<tr>\n<td><sup>2<\/sup>\u00a0Waldenstr\u00f6m\u2019s\u00a0Macroglobulinemia Foundation of Canada.\u00a0<a href=\"https:\/\/wmfc.ca\/what-we-do\/what-is-wm\/\">https:\/\/wmfc.ca\/what-we-do\/what-is-wm\/<\/a>.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/figure>\n<p><!-- \/wp:table --> <!-- wp:image --><\/p>\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20210408005194r1&amp;sid=acqr8&amp;distro=nx&amp;lang=en\" alt=\"\" \/><\/figure>\n<p><!-- \/wp:image --> <!-- wp:paragraph --><\/p>\n<p id=\"mmgallerylink\">View source version on\u00a0<a href=\"https:\/\/businesswire.com\/\">businesswire.com<\/a>:\u00a0<a href=\"https:\/\/www.businesswire.com\/news\/home\/20210408005194\/en\/\">https:\/\/www.businesswire.com\/news\/home\/20210408005194\/en\/<\/a><\/p>\n<p><!-- \/wp:paragraph --> <!-- wp:paragraph --><\/p>\n<p><strong>Investors<\/strong><br \/>\nCraig West<br \/>\n(857) 302-5189<br \/>\n<a href=\"mailto:ir@beigene.com\">ir@beigene.com<\/a><\/p>\n<p><!-- \/wp:paragraph --> <!-- wp:paragraph --><\/p>\n<p><strong>Media<\/strong><br \/>\nLiza Heapes\u00a0or\u00a0Vivian Ni<br \/>\n(857) 302-5663 or (857) 302-7596<br \/>\n<a href=\"mailto:media@beigene.com\">media@beigene.com<\/a><\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<\/div>\r\n                                                                            <\/div>\r\n                                    \r\n                                                                             <!-- <style>\r\n                                            .after-buttons {\r\n                                                display: flex; gap: 30px;\r\n                                             }\r\n\r\n                                            .after-buttons a {\r\n                                                flex: ;\r\n                                            }\r\n                                         <\/style> -->\r\n                                                                             <style>\r\n                                            .after-buttons {\r\n                                                display: flex; gap: 30px; flex-wrap: wrap;\r\n                                            }\r\n\r\n                                            .after-buttons a {\r\n                                                flex: 0 1 auto;\r\n                                            }\r\n\r\n                                            .after-buttons.multiple > div {\r\n                                                flex: 0 1 calc(50% - 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