Posted by Michael Wonder on 14 Apr 2020
China National Medical Products Administration approves BeiGene’s tislelizumab for patients with previously treated locally advanced or metastatic urothelial carcinoma
10 April 2020 - Second approval of tislelizumab in China, first in solid tumour
BeiGene today announced that its anti-PD-1 antibody tislelizumab has received approval from the China National Medical Products Administration as a treatment for patients with locally advanced or metastatic urothelial carcinoma with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neo-adjuvant or adjuvant treatment with platinum-containing chemotherapy.
Following tislelizumab’s initial approval in classical Hodgkin’s lymphoma by the NMPA in December 2019, this is the second indication approved for tislelizumab, and the first in a solid tumor indication. The supplemental new drug application was previously granted priority review by the Center for Drug Evaluation of the NMPA.
