Japan approve Daiichi Sankyo’s Enhertu as a second-line treatment for gastric cancer
pharmafile | April 9, 2026 | News story | | Oncology
The Japan Pharmaceuticals and Medical Devices Agency (PMDA) has accepted the updated prescribing information for Daiichi Sankyo’s Enhertu (trastuzumab), a specifically engineered HER2 directed DXd antibody drug conjugate (ADC).
Following a review of the data from the DESTINY-Gastric04 phase 3 trial, Enhertu can now be used, in Japan as a second-line treatment for patients with HER2 positive unresectable advanced or recurrent gastric cancer.
Prior to this trial, no other HER2-directed medicine had demonstrated a survival benefit in the second-line metastatic setting in a randomised clinical trial.
Yuki Abe, Head of R&D Division in Japan and Head of Research, Daiichi Sankyo, said: “Gastric cancer can be particularly challenging to treat and is associated with a poor prognosis, especially in the metastatic setting where outcomes are notably worse for patients with disease progression after first-line treatment.”
In the trial, the treatment demonstrated a 30% reduction in risk of death compared to ramucirumab plus paclitaxel, and a median overall survival (OS) of 14.7 months compared to 11.4 months with ramucirumab plus paclitaxel.
Adverse reactions occurred in 93% of patients treated with Enhertu, with the most common including fatigue, decreased neutrophil count, nausea, decreased appetite and decreased leukocyte count.
In Japan, Enhertu is approved with a warning in its prescribing information for interstitial lung disease (ILD), which occurred in 11.6% of patients across multiple clinical trials.
As ILD cases, including fatal cases, have occurred in patients treated with Enhertu, the treatment must be used in close collaboration with a respiratory disease expert, among other conditions.
Results were presented at the 2025 American Society of Clinical Oncology Annual Meeting and published in The New England Journal of Medicine.
Based on results from the DESTINY-Gastric01 phase 2 trial, Enhertu had previously been approved as a third-line treatment.
In Japan, gastric cancer affected more than 125,000 people in 2022, with over 43,000 deaths. Gastric cancer is the third most common cancer in Japan, with approximately one in five gastric cancers considered HER2 positive.
