Brukinsa MAA validated by EMA to treat Waldenström’s macroglobulinemia .- BeiGene

BeiGene, Ltd. announced that its marketing authorization application (MAA) for Brukinsa (zanubrutinib) for the treatment of patients with Waldenström’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). Clinical data in the MAA include the Phase III 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..