Posted by Michael Wonder on 14 Mar 2022
InnoCare announces acceptance of supplemental new drug application for orelabrutinib in relapsed or refractory Waldenström's macroglobulinemia in China
14 March 2022 - InnoCare Pharma announced today that the Center for Drug Evaluation of the China National Medical Products Administration accepted a supplemental new drug application for Bruton's tyrosine kinase inhibitor orelabrutinib for the treatment of patients with relapsed or refractory Waldenström's macroglobulinemia.
On 25 December 2020, orelabrutinib received approval from National Medical Products Administration in two indications: the treatment of patients with relapsed/refractory chronic lymphocytic leukaemia/small lymphocytic lymphoma, and the treatment of patients with relapsed/refractory mantle cell lymphoma.
