BeiGene, Ltd. (NASDAQ:BGNE, HKEX: 06160))))), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that its New Drug Submission (NDS) for BRUKINSA® (zanubrutinib) for the treatment of patients with Waldenström's macroglobulinemia (WM) has been accepted by Health Canada and granted priority review status.
"Following our recent submissions for WM in Europe and Australia, we are pleased to continue advancing the global registration of BRUKINSA with this new filing in Canada. BRUKINSA has approvals in the U.S. and China and is being developed with the goal of making it accessible to patients around the world who can benefit from it. For patients with WM, BRUKINSA has demonstrated efficacy and clinically meaningful improvements in safety and tolerability," said Jane Huang, M.D., Chief Medical Officer, Hematology at BeiGene. "We believe that BRUKINSA's safety advantages over ibrutinib as demonstrated in our head-to-head ASPEN trial, including reduced risk for certain cardiovascular issues, may help it become a preferred treatment option for patients with WM in Canada and around the world."
Clinical data in the Canadian NDS include data from the Phase 3 randomized, open-label, multicenter ASPEN clinical trial (NCT03053440) that evaluated zanubrutinib versus ibrutinib in patients with relapsed/refractory (R/R) or treatment-naïve (TN) WM, which were presented at the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program and the 25th European Hematology Association (EHA) Congress. In that study, zanubrutinib demonstrated more frequent VGPRs (28.4% vs.19.2% in overall population), although the primary endpoint of statistical superiority related to deep response (VGPR or better) was not met. Zanubrutinib also demonstrated advantages in safety and tolerability compared to ibrutinib. The safety package in the NDS includes pooled safety data from 779 patients with B-cell malignancies treated with BRUKINSA in six clinical trials.