Posted by Michael Wonder on 24 Aug 2021
BeiGene announces acceptance of a supplemental biologics license application in China for tislelizumab in nasopharyngeal cancer
22 August 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-PD-1 antibody tislelizumab in combination with chemotherapy as a first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer.
The supplemental biologics license application is supported by clinical results from a randomised, double-blind, Phase 3 clinical trial RATIONALE 309 to evaluate the efficacy and safety of tislelizumab combined with gemcitabine and cisplatin versus placebo combined with gemcitabine and cisplatin as a first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer.
