ENHERTU now available in Japan as first ADC for the second-line treatment of patients with HER2 positive metastatic gastric cancer

CAR-T Digest - August 2020

23 March 2026: ENHERTU now available in Japan as first ADC for the second-line treatment of patients with HER2 positive metastatic gastric cancer

Japan’s PMDA has approved a label update for ENHERTU, expanding its indication to second-line treatment of HER2-positive unresectable or metastatic gastric cancer, moving it earlier from the previous third-line setting
The approval is supported by the global Phase 3 DESTINY-Gastric04 trial, which evaluated ENHERTU versus ramucirumab plus paclitaxel in patients progressing after trastuzumab-based therapy
ENHERTU demonstrated a statistically significant overall survival benefit, reducing the risk of death by 30% (HR: 0.70) and improving median OS to 14.7 months vs. 11.4 months, establishing clinical superiority over standard of care
The safety profile remained consistent with prior studies, with no new signals identified; however, interstitial lung disease (ILD) remains an important risk requiring proactive monitoring and management in clinical practice
This expansion addresses a key gap in treatment sequencing, as no HER2-directed therapy had previously demonstrated an overall survival benefit in the second-line metastatic setting