Posted by Michael Wonder on 21 Jun 2021
BeiGene announces China NMPA approval of Brukinsa (zanubrutinib) for the treatment of patients with relapsed or refractory Waldenström’s macroglobulinaemia
18 June 2021 - Third approval for Brukinsa in China and second approval in Waldenström’s macroglobulinaemia worldwide.
BeiGene today announced that Brukinsa (zanubrutinib) has received conditional approval from the China National Medical Products Administration for the treatment of adult patients with Waldenström’s macroglobulinaemia who have received at least one prior therapy.
The supplemental new drug application was previously granted priority review by the Center for Drug Evaluation of the NMPA in October 2020.
