Core Viewpoint - The FDA has granted Breakthrough Therapy Designation to izalontamab brengitecan (iza-bren) for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) patients who have progressed after EGFR-TKI and platinum-based chemotherapy, indicating significant clinical benefits over existing therapies [1][2]. Group 1: FDA Breakthrough Therapy Designation - The designation is based on clinical research data from multiple studies, including BL-B01D1-101, BL-B01D1-203, and BL-B01D1-LUNG-101 [2]. - This recognition validates the reliability of existing data and highlights the unmet clinical needs faced by patients after EGFR-TKI and platinum-based chemotherapy [2][4]. Group 2: Clinical Context and Market Need - NSCLC accounts for approximately 80% of all lung cancer cases and remains a leading cause of cancer-related deaths globally [3]. - In Western populations, 10% to 15% of NSCLC patients have EGFR mutations, while in Asian populations, this figure can be as high as 50% [3]. Group 3: Drug Development and Clinical Trials - Iza-bren is a globally innovative EGFR×HER3 dual antibody ADC that has entered Phase III clinical trials [4]. - The drug is currently involved in over 40 clinical trials across various tumor types in China and the U.S., with several Phase III trials ongoing for NSCLC, small cell lung cancer, breast cancer, and nasopharyngeal carcinoma [5].
百利天恒iza-bren获得FDA突破性疗法认定 用于治疗局部晚期或转移性非小细胞肺癌患者