ENHERTU approved in China as the first and only HER2 directed ADC for the second-Line treatment of patients with HER2 positive metastatic gastric cancer

CAR-T Digest - August 2020

Weekly Digest - January 2026

22 January 2026: ENHERTU approved in China as the first and only HER2 directed ADC for the second-Line treatment of patients with HER2 positive metastatic gastric cancer

ENHERTU (trastuzumab deruxtecan) has been approved in China for the second-line treatment of adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have progressed after a trastuzumab-based regimen, becoming the first and only HER2-directed ADC approved in this setting
This approval is based on results from the Phase 3 DESTINY-Gastric04 trial, the first randomized study to demonstrate an overall survival benefit for a HER2-targeted therapy in second-line metastatic gastric cancer, addressing a long-standing treatment gap in clinical practice
In the study, ENHERTU reduced the risk of death by 30% compared with ramucirumab plus paclitaxel, delivering a median overall survival of 14.7 months versus 11.4 months, alongside improvements in progression-free survival and objective response rate
The decision is particularly impactful in China, which accounts for more than one-third of global gastric cancer cases and where most patients are diagnosed at an advanced stage, with roughly one in five tumors classified as HER2 positive
This marks the sixth approval for ENHERTU in China across three tumor types in less than three years, reinforcing its expanding role in precision oncology and signaling a shift toward targeted therapies in earlier lines of treatment for HER2-positive gastric cancer