Posted by Michael Wonder on 04 Jun 2020
BeiGene announces the approval of Brukinsa (zanubrutinib) in China for patients with relapsed/refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma and relapsed/refractory mantle cell lymphoma
3 June 2020 - First approvals for Brukinsa in China and its first indication for relapsed/refractory chronic lymphocytic leukaemia/small lymphocytic lymphoma.
BeiGene today announced that its BTK inhibitor Brukinsa (zanubrutinib) has received approval from the China National Medical Products Administration in two indications – the treatment of adult patients with chronic lymphocytic leukaemia/small lymphocytic lymphoma who have received at least one prior therapy, and the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy.
Both new drug applications were previously granted priority review by the Center for Drug Evaluation of the NMPA.
