BeiGene Announces EMA Acceptance of its Marketing Authorization Application for BRUKINSA® (Zanubrutinib) for the Treatment of Patients with WM
On June 18, 2020, BeiGene, Ltd. (“BeiGene” or the “Company”), a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, announced thatits marketing authorization application (MAA) for BRUKINSA® (zanubrutinib) for the treatment of patients with Wald Enstrom’s macroglobulinemia (WM) who have received at least one prior therapy or as first-line treatment for patients unsuitable for chemo-immunotherapy has been validated for regulatory review by the European Medicines Agency (EMA).
“This is our first submission to the EMA and the first for WM, marking a significant milestone for BRUKINSA, which has demonstrated efficacy and clinically meaningful improvements in safety and tolerability in patients with WM compared to the first-generation BTK inhibitor, ibrutinib, in our head-to-head ASPEN trial. BRUKINSA has been approved in the U.S. and China in other indications, and we are excited to continue its broad, global development program to help patients with B-cell lymphomas,” said Jane Huang, M.D., Chief Medical Officer, Hematology at BeiGene.
“WM is typically a disease of older individuals, and we are hopeful that BRUKINSA’s cardiovascular safety advantages over ibrutinib may help it become a preferred treatment option for patients in Europe with WM.”
Clinical data in the MAA include 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 was recently presented at the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program and the 25th European Hematology Association (EHA) Congress. The safety package in the MAA included pooled safety data from 779 patients with B-cell malignancies treated with BRUKINSA in six clinical trials.