第一三共/阿斯利康(AZN.US)“德曲妥珠单抗”在华获批治疗HER2阳性胃癌

Core Viewpoint - The approval of trastuzumab deruxtecan for a new indication in China marks a significant milestone for Daiichi Sankyo and AstraZeneca, expanding its use in treating HER2-positive gastric cancer patients [1] Group 1: Drug Approval and Indication - Trastuzumab deruxtecan has received approval from the National Medical Products Administration of China for use in adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have previously received a treatment regimen containing trastuzumab [1] - This new indication is the sixth approved use of trastuzumab deruxtecan in China and the second indication related to HER2-positive gastric cancer [1] Group 2: Clinical Trial Results - The approval is based on results from the international, multicenter, randomized, open-label phase 3 study DESTINY-Gastric04, which demonstrated statistically significant and clinically meaningful improvements in overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) [1] - The safety profile of trastuzumab deruxtecan was found to be acceptable and manageable, consistent with known safety characteristics, with no new safety issues identified [1] - Results from the DESTINY-Gastric04 study were presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting and published in the New England Journal of Medicine [1]