Posted by Michael Wonder on 23 Mar 2026
Enhertu now available in Japan as first antibody drug conjugate for the second-line treatment of patients with HER2 positive metastatic gastric cancer
23 March 2026 - Based on DESTINY-Gastric04 Phase 3 trial results that showed Enhertu demonstrated statistically significant and clinically meaningful improvement in overall survival compared to ramucirumab plus paclitaxel.
The Japan Pharmaceuticals and Medical Devices Agency (PMDA) has accepted the update of the Enhertu (trastuzumab deruxtecan) prescribing information following review of data from the DESTINY-Gastric04 Phase 3 trial, which now expands the use of Enhertu in Japan to include the second-line treatment of patients with HER2 positive (immunohistochemistry (IHC) 3+ or IHC 2+/in situ hybridisation +) unresectable advanced or recurrent gastric cancer.
Enhertu previously was approved as a third-line treatment based on the results from the DESTINY-Gastric01 Phase 2 trial.
