Posted by Michael Wonder on 23 Jul 2018
BeiGene announces plan to pursue accelerated approval in the U.S. of BTK inhibitor zanubrutinib in Waldenström macroglobulinaemia
22 July 2018 - Fast track designation granted by U.S. FDA.
BeiGene today announced that its investigational BTK inhibitor zanubrutinib has been granted fast track designation by the U.S. FDA for the treatment of patients with Waldenström macroglobulinemia (WM).
Based on BeiGene’s discussions with the FDA, internal review of available data from its global Phase 1 trial of zanubrutinib in patients with WM, and supported by the fast track designation, BeiGene is preparing to submit in the first half of 2019 a new drug application to pursue an accelerated approval of zanubrutinib for patients with WM based on results from the global Phase 1 study.
