Posted by Michael Wonder on 19 Jun 2020
BeiGene announces European Medicines Agency acceptance of its marketing authorisation application for Brukinsa (zanubrutinib) for the treatment of patients with Waldenström’s macroglobulinaemia
18 June 2020 - BeiGene today announced that its marketing authorisation application for Brukinsa (zanubrutinib) for the treatment of patients with Waldenström’s macroglobulinaemia 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.
Clinical data in the application include the Phase 3 randomised, open-label, multicenter ASPEN clinical trial that evaluated zanubrutinib versus ibrutinib in patients with relapsed/refractory or treatment naïve Waldenström’s macroglobulinaemia which was recently presented at the 2020 American Society of Clinical Oncology Virtual Scientific Program and the 25th European Hematology Association Congress.
The safety package in the application included pooled safety data from 779 patients with B-cell malignancies treated with Brukinsa in six clinical trials.
