China’s National Medical Products Administration (NMPA) has approved ENHERTU® (trastuzumab deruxtecan) for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received one prior trastuzumab-based regimen. The decision marks a significant expansion of treatment options in a disease area with high unmet medical need, particularly in China, which accounts for more than one-third of global gastric cancer cases.
ENHERTU is a HER2-directed antibody-drug conjugate (ADC) discovered by Daiichi Sankyo and jointly developed and commercialized with AstraZeneca. The therapy had previously received conditional approval in China for third-line or later treatment based on phase 2 clinical data. The latest approval moves the drug into the second-line setting, where no other HER2-targeted therapy had previously demonstrated a survival benefit in a randomized phase 3 trial.
The approval is based on results from the global phase 3 DESTINY-Gastric04 study, which were presented as a late-breaking oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and published simultaneously in The New England Journal of Medicine. In the trial, ENHERTU reduced the risk of death by 30% compared with the standard regimen of ramucirumab plus paclitaxel in patients with second-line HER2-positive unresectable or metastatic gastric or GEJ adenocarcinoma.
Median overall survival reached 14.7 months in patients treated with ENHERTU, compared with 11.4 months in the control arm. The drug also demonstrated improvements in progression-free survival, objective response rate, and duration of response, reinforcing its clinical benefit over existing therapies.
China’s Center for Drug Evaluation (CDE) had granted ENHERTU Breakthrough Therapy Designation for this indication in 2020, citing strong early efficacy data and significant unmet clinical need. The drug also received Priority Review, enabling approval within approximately six months.
Experts say the decision represents a milestone for gastric cancer care in China, where around 65% of patients are diagnosed at an advanced stage and outcomes remain poor. Company executives from both Daiichi Sankyo and AstraZeneca highlighted the approval as evidence of ENHERTU’s growing role across multiple lines of therapy and tumor types.
ENHERTU is now approved in China for six indications within less than three years, and further studies are ongoing to evaluate its potential use as a first-line treatment for HER2-positive metastatic gastric cancer.