Posted by Michael Wonder on 08 Jul 2021
BeiGene announces acceptance of a supplemental biologics license application in China for tislelizumab in oesophageal squamous cell carcinoma
7 July 2021 - BeiGene today announced that the Center for Drug Evaluation of the China National Medical Products Administration has accepted a supplemental biologics license application for anti-PD1 antibody tislelizumab for the treatment of patients with locally advanced or metastatic oesophageal squamous cell carcinoma who have disease progression following or are intolerant to first-line standard chemotherapy.
The application is supported by clinical results from a randomized, open-label, multi-center, global Phase 3 clinical trial RATIONALE 302 to evaluate the efficacy and safety of tislelizumab as a second-line treatment for patients with locally advanced or metastatic oesophageal squamous cell carcinoma compared to chemotherapy.
