BeiGene Launches BRUKINSA (Zanubrutinib) in Canada for Patients with Waldenström’s Macroglobulinemia

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.

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.

“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.”

“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.

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 (MYD88^MUT). 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.

The overall safety profile of BRUKINSA is based on pooled data from 779 patients with B-cell malignancies treated with BRUKINSA in clinical trials.

The recommended total daily dose of BRUKINSA is 320mg.

“Zanubrutinib is a newly approved treatment in Canada. We are glad to learn that this second-generation BTK inhibitor is now available for Canadian patients,” said Christine Chen, M.D., Med, FRCPC, Associate Professor at the University of Toronto and Clinical Investigator at Princess Margaret Cancer Centre.