Posted by Michael Wonder on 10 Sep 2020
BeiGene announces acceptance and priority review by Health Canada of new drug submission for Brukinsa (zanubrutinib) in Waldenström’s macroglobulinaemia
9 September 2020 - BeiGene today announced that its new drug submission for Brukinsa (zanubrutinib) for the treatment of patients with Waldenström’s macroglobulinaemia has been accepted by Health Canada and granted priority review status.
Clinical data in the Canadian new drug submission include data from the Phase 3 randomised, open-label, multi-centre ASPEN clinical trial that evaluated zanubrutinib versus ibrutinib in patients with relapsed/refractory or treatment naïve WM, which were presented at the 2020 American Society of Clinical Oncology Virtual Scientific Program and the 25th European Hematology Association Congress.
