Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan) has received approval from China’s National Medical Products Administration (NMPA) for adults with locally advanced or metastatic human epidermal growth factor receptor 2 (HER2) positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.
The approval applies to patients who have had one prior trastuzumab-based regimen.
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By GlobalDataEnhertu is a specifically engineered HER2-directed DXd antibody drug conjugate discovered by Daiichi Sankyo and jointly developed with AstraZeneca.
The approval is supported by data from the DESTINY-Gastric04 Phase III trial.
The China Center for Drug Evaluation previously granted breakthrough therapy designation for Enhertu in this indication. The therapy has also received priority review status, allowing expedited approval.
In DESTINY-Gastric04, Enhertu showed a 30% reduction in risk of death against ramucirumab plus paclitaxel for second-line HER2-positive unresectable or metastatic gastric or GEJ adenocarcinoma. Median overall survival was 14.7 months with Enhertu versus 11.4 months for the comparator group.
Progression-free survival analysis indicated a 26% lower risk of disease progression or death with Enhertu. Confirmed objective response rate was 44.3% for Enhertu, with seven complete responses and 97 partial responses.
Daiichi Sankyo China president Michio Hayashi said: “This sixth approval for Enhertu in China in less than three years fully demonstrates the potential of this innovative medicine to make significant contributions in clinical practice.
“DESTINY-Gastric04 is the first randomised Phase III trial ever to show a survival benefit in the second-line HER2-positive metastatic gastric cancer setting and also confirmed the results of the DESTINY-Gastric01 and DESTINY-Gastric06 trials.”
Enhertu is also under evaluation in Phase III trials DESTINY-Gastric05 and ARTEMIDE-Gastric01 as a possible first-line treatment option for HER2-positive metastatic gastric cancer.
In September 2025, Daiichi Sankyo and AstraZeneca received priority review from the US Food and Drug Administration (FDA) for the supplemental biologics licence application (sBLA) of Enhertu in combination with pertuzumab.
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