NEW YORK – Last Friday, BeiGene said that China's National Medical Products Administration approved its anti-PD-1 antibody tislelizumab for PD-L1 high expressing advanced or metastatic urothelial carcinoma patients who have progressed during or after platinum chemotherapy.
This marks the second approval in the country for tislelizumab after garnering approval last year for classical Hodgkin's lymphoma.
The NMPA approval is based on results from a single-arm, Phase II trial of tislelizumab in patients in China and South Korea with PD-L1-positive locally advanced or metastatic urothelial carcinoma who previously received platinum-containing chemotherapy. Investigators observed an objective response rate of 24.8 percent and a complete response rate of 9.9 percent.
"We hope our broad development program for tislelizumab, which encompasses 15 potentially registration-enabling trials globally and in China, in indications including lung, liver, esophageal, gastric, nasopharyngeal, and MSI-H or dMMR cancers, in addition to classical Hodgkin's lymphoma and urothelial carcinoma, will continue its momentum and benefit more patients," BeiGene SVP Wendy Yan said in a statement.