Tislelizumab sBLA accepted by China's regulator for ESCC

Sino-American biotech BeiGene (Nasdaq: BGNE) said yesterday that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a supplemental Biologics License Application (sBLA) for its anti-PD1 antibody tislelizumab for the treatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have disease progression following or are intolerant to first-line standard chemotherapy.

“We are excited to submit the eighth marketing application for tislelizumab, of which five have been approved in China. As the first global Phase III ESCC clinical trial, the differences in clinical practice in various countries and regions have been fully taken into account, which indicates the result is fully globally representative,” commented Dr Yong (Ben) Ben, chief medical officer, immuno-oncology at BeiGene.

“The results demonstrated improved efficacy of tislelizumab monotherapy over chemotherapy in second-line treatment for patients with locally advanced or metastatic ESCC and the potential to benefit patients with improved overall survival (OS) compared to chemotherapy. We look forward to further communication with CDE and hope this medicine will benefit Chinese patients with locally advanced or metastatic ESCC soon,” he added.