百利天恒自研创新药iza-bren又一适应症被正式纳入优先审评

Core Viewpoint - The drug ADCiza-bren (BL-B01D1), developed by Sichuan BaiLi Tianheng Pharmaceutical Co., Ltd., has been included in the priority review process by the Center for Drug Evaluation (CDE) for a new indication in treating recurrent or metastatic esophageal squamous cell carcinoma that has failed previous PD-1/PD-L1 monoclonal antibody combined with platinum-based chemotherapy [1]. Group 1 - ADCiza-bren is the first ADC drug to achieve positive results in both progression-free survival (PFS) and overall survival (OS) in a Phase III clinical trial for esophageal cancer [1]. - The drug has previously been included in the priority review process for its first indication, advanced nasopharyngeal carcinoma, which was accepted by CDE on November 21 of the same year [1]. - As of now, ADCiza-bren has received seven breakthrough therapy designations from CDE and one from the U.S. Food and Drug Administration (FDA) [2].