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BeiGene Launches BRUKINSA in Canada for Patients with Waldenström's Macroglobulinemia

BeiGene Launches BRUKINSA in Canada for Patients with Waldenström's Macroglobulinemia

BEY Gene公司在加拿大推出BRUKINSA治疗Waldenström巨球蛋白血症患者
Benzinga Real-time News ·  2021/04/08 19:02
  • BRUKINSA is now commercially available in Canada following approval in March.
  • Canadian patients now have access to the myBeiGene® patient support program.
  • BRUKINSA在3月份获得批准后,现已在加拿大投入商业使用。
  • 加拿大患者现在可以使用mybeGene®患者支持计划。

BeiGene, Ltd. (NASDAQ:BGNE, HKEX: 06160))))), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced the official launch of BRUKINSA® (zanubrutinib) in Canada for the treatment of adult patients with Waldenström's macroglobulinemia (WM). BRUKINSA was authorized for sale by Health Canada in this indication on March 1, 2021, following the previous grant of priority review in September 2020.

贝吉恩有限公司(纳斯达克:BGNE香港交易所股票代码:06160),致力于在全球范围内开发和商业化创新药物的商业期生物技术公司今天宣布,BRUKINSA®(扎努布鲁替尼)正式在加拿大推出,用于治疗成年沃尔登斯特伦巨球蛋白血症(WM)患者。在2020年9月的上一次优先审查之后,BRUKINSA于2021年3月1日被加拿大卫生部批准在这一适应症中出售。

In tandem with the commercial launch of BRUKINSA, the myBeiGene® patient support program is available in Canada to support patients, caregivers, and healthcare providers with access to BRUKINSA.

在BRUKINSA商业化推出的同时,加拿大也推出了mybeGene®患者支持计划,为能够访问BRUKINSA的患者、护理者和医疗保健提供者提供支持。

"We are thrilled to officially launch BRUKINSA in Canada, making this potentially best-in-class BTK inhibitor available to Canadian WM patients. Since the approval in Canada five weeks ago, our team has been working to set up distribution channels across the country for a speedy launch," said Peter Brenders, General Manager of Canada at BeiGene. "Together 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."

“我们很高兴能在加拿大正式推出BRUKINSA,为加拿大的西医患者提供这种可能是同类中最好的BTK抑制剂。自从五周前在加拿大获得批准以来,我们的团队一直在努力在全国建立分销渠道,以便迅速推出。”北京基因公司加拿大总经理彼得·布兰德斯说。我们正在努力与mybeGene患者支持计划一起,提供全面的财政援助、疾病教育和情感支持,以确保加拿大患者能够获得治疗。“

"On behalf of the Waldenström's Macroglobulinemia Foundation of Canada (WMFC), we are pleased to see BeiGene's launch of BRUKINSA as a WM treatment in Canada following the approval last month. We hope this will help expand access to an important treatment option for Canadian WM patients," commented Paul Kitchen, Chair of the Board at WMFC.

WMFC董事会主席Paul Kitchen评论说:“我们代表Waldenström的加拿大巨球蛋白血症基金会(WMFC)高兴地看到,继上个月获得批准后,北京基因公司在加拿大推出了BRUKINSA作为一种西医疗法。我们希望这将有助于扩大加拿大西医患者获得一种重要治疗选择的机会。”

The approval in Canada for 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-naïve (TN) WM who harbor a MYD88 mutation (MYD88MUT). In the ASPEN trial, 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.

加拿大对BRUKINSA的批准是基于3期Aspen临床试验的疗效结果,这是一项随机的、开放标签的多中心试验(NCT03053440),该试验评估了BRUKINSA与伊布鲁替尼在携带MYD88突变(MYD88突变)或治疗初治(TN)的复发/难治(R/R)或治疗-幼稚(TN)WM患者中的比较。MYD88MUT)。在Aspen试验中,BRUKINSA显示出比伊布鲁替尼更高的数值上的非常好的部分应答(VGPR)率和良好的安全性,尽管与深度应答(VGPR或更好)相关的统计学优势的主要终点没有达到。

译文内容由第三方软件翻译。


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