Tislelizumab (tislelizumab) approved in China for the treatment of locally advanced or metastatic urothelial carcinoma (UC)

Tislelizumab

On April 10, 2020, BeiGene (tislelizumab) was approved by the China National Food and Drug Administration for the treatment of locally advanced or metastatic urothelial carcinoma (UC).

This is the second indication for tislelizumab approved in China and the first PD-1 approved in China for the treatment of UC.
The marketing application of tislelizumab for the treatment of UC is based on the results of a pivotal phase II clinical study (CTR20170071), which enrolled a total of 113 patients with previously treated PD-L1-positive locally advanced or metastatic disease. Among Chinese and Korean UC patients, the median follow-up time was 8 months. The study results showed that the overall response rate (ORR) of tislelizumab monotherapy in the second-line treatment of UC was 23.1%, of which the complete response rate (CR) was 7.7% and the partial response rate (PR) was 15.4%.