BeiGene presents updated Phase 1 data on zanubrutinib
BeiGene announced updated results from the Phase 1 clinical trial of its investigational BTK inhibitor zanubrutinib, in an oral presentation at the 10th International Workshop on Waldenstrom's Macroglobulinemia. The IWWM meeting is taking place in New York City from October 11-13, 2018. "As we prepare our first U.S. New Drug Application filing for zanubrutinib, which we expect to file in the first half of 2019 in patients with Waldenstrom's Macroglobulinemia, we are pleased to update data in patients with WM from the Phase 1 trial that will support our filing. With more than 70 patients with WM now treated, we continue to see a high rate of deep and durable responses across genotypes, including high rates of overall, major, and very good partial responses," commented Jane Huang, M.D., Chief Medical Officer, Hematology, at BeiGene. "We believe that the maturing data across B-cell malignancies continue to support a multi-regional approval strategy for zanubrutinib, including the ongoing NDA review in China for zanubrutinib in patients with relapsed/refractory mantle cell lymphoma by The National Medical Products Administration. We are hopeful that zanubrutinib, if approved, will represent a valuable treatment option across the globe for patients with several forms of B-cell malignancy."