百利天恒双抗ADC食管鳞癌适应证被纳入优先审评

Core Viewpoint - The National Medical Products Administration (NMPA) has prioritized the review of Iza-bren (BL-B01D1, an EGFR/HER3 dual antibody ADC) for the treatment of recurrent or metastatic esophageal squamous cell carcinoma in patients who have failed previous PD-1/PD-L1 monoclonal antibody combined with platinum-based chemotherapy [1] Group 1 - Iza-bren is the second indication to be prioritized for review, with the first being nasopharyngeal carcinoma, which was prioritized in September 2025 [1] - The new drug application for the nasopharyngeal carcinoma indication was accepted by the NMPA in November 2025 [1] - In the same month, the Phase III study (BL-B01D1-305) for the treatment of esophageal squamous cell carcinoma achieved significant improvements in both progression-free survival (PFS) and overall survival (OS) in its pre-specified interim analysis [1]