百利天恒：与BMS合作的iza-bren用于治疗非小细胞肺癌获FDA突破性疗法认定

Core Viewpoint - The company announced that its drug Iza-bren has received Breakthrough Therapy Designation from the FDA for the treatment of advanced EGFR-mutant non-small cell lung cancer (NSCLC) after failure of prior EGFR-TKI and platinum-based chemotherapy [1][2]. Group 1: FDA Breakthrough Therapy Designation - Iza-bren, a dual-target antibody-drug conjugate (ADC) targeting EGFR and HER3, has been granted Breakthrough Therapy Designation by the FDA, indicating its potential to significantly outperform existing standard therapies [1][2]. - This designation is based on clinical trial data from studies BL-B01D1-101, BL-B01D1-203 in China, and BL-B01D1-LUNG-101 in the US/Europe, demonstrating promising efficacy and manageable safety in patients with EGFR mutations who progressed after third-generation EGFR-TKIs and platinum chemotherapy [2]. Group 2: Clinical Development and Market Position - Iza-bren is the first-in-class and only ADC targeting EGFR and HER3 that has entered Phase III clinical trials, with over 40 ongoing clinical trials for various tumor types in China and the US [2]. - The drug has five additional indications included in the list of breakthrough therapies by the National Medical Products Administration (NMPA) in China, highlighting its broad potential in oncology [2].