The combination of trastuzumab deruxtecan has been approved for the treatment of HER2-positive gastric cancer in China by Daiichi Sankyo/Astrazeneca PLC Sponsored ADR (AZN.US).

On January 22, Daiichi Sankyo/AstraZeneca PLC Sponsored ADR (AZN.US) jointly announced that the injection of trastuzumab deruxtecan has officially received approval from the China National Medical Products Administration, for use as a single agent in the treatment of locally advanced or metastatic HER2-positive adult gastric or gastroesophageal junction adenocarcinoma patients who have previously received a trastuzumab-containing treatment regimen. It is reported that this indication is the sixth indication for trastuzumab deruxtecan approved in China, and the second indication related to HER2-positive gastric cancer. Trastuzumab deruxtecan is a HER2-targeted DXd antibody-drug conjugate developed using Daiichi Sankyo's unique technology, designed by Daiichi Sankyo and jointly developed and commercialized with AstraZeneca PLC Sponsored ADR. The approval of trastuzumab deruxtecan for the new indication of gastric cancer is based on the results of the international multicenter, randomized, open-label Phase 3 study DESTINY-Gastric04. In the DESTINY-Gastric04 study, trastuzumab deruxtecan demonstrated statistically significant and clinically meaningful improvements in the primary endpoint of overall survival (OS), as well as the secondary endpoints of progression-free survival (PFS) and objective response rate (ORR). Its safety profile was acceptable, manageable overall, consistent with known safety characteristics, and no new safety issues were identified. The study results were presented in the form of a major research oral report at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in the New England Journal of Medicine.