China approves Daiichi Sankyo/AstraZeneca’s Enhertu for advanced gastric cancer

CHINA—Daiichi Sankyo and AstraZeneca have secured regulatory approval in China for their cancer drug Enhertu (trastuzumab deruxtecan), marking a significant milestone for patients battling advanced stomach cancers.

The National Medical Products Administration (NMPA) has authorized the treatment for adults with locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction adenocarcinoma.

The approval specifically targets patients who have already undergone one prior trastuzumab-based treatment regimen.

This means the drug offers a crucial second-line option for individuals whose cancer has progressed despite initial therapy.

Enhertu represents a sophisticated approach to cancer treatment, functioning as a specifically engineered HER2-directed DXd antibody drug conjugate that Daiichi Sankyo originally discovered before partnering with AstraZeneca for joint development.

The regulatory decision draws its foundation from compelling evidence presented in the DESTINY-Gastric04 Phase III clinical trial.

This comprehensive study demonstrated that Enhertu delivered meaningful benefits compared to existing treatment options.

Chinese regulators had previously recognized the therapy’s potential by granting it breakthrough therapy designation for this specific indication, which subsequently led to priority review status and expedited the approval process.

Clinical trial results revealed substantial improvements in patient outcomes.

When compared to the combination of ramucirumab plus paclitaxel, Enhertu achieved a 30% reduction in the risk of death for patients with second-line HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

The median overall survival was 14.7 months in patients receiving Enhertu, compared with 11.4 months in the comparator group.

The progression-free survival analysis further reinforced the drug’s effectiveness, showing that patients treated with Enhertu faced a 26% lower risk of disease progression or death.

The confirmed objective response rate stood at 44.3% for Enhertu, which included seven complete responses alongside 97 partial responses, demonstrating the treatment’s ability to shrink or eliminate tumors in a significant proportion of patients.

Michio Hayashi, president of Daiichi Sankyo China, emphasized the rapid adoption of the therapy across multiple indications.

He noted that this represents the sixth approval for Enhertu in China within less than three years, underscoring the innovative medicine’s capacity to deliver meaningful contributions in clinical practice.

Hayashi highlighted that DESTINY-Gastric04 stands as the first randomized Phase III trial to demonstrate a survival benefit in the second-line HER2-positive metastatic gastric cancer setting, while also confirming findings from the earlier DESTINY-Gastric01 and DESTINY-Gastric06 trials.

The pharmaceutical partners continue to explore additional applications for Enhertu through ongoing research.

The drug is currently under evaluation in Phase III trials DESTINY-Gastric05 and ARTEMIDE-Gastric01 as a potential first-line treatment option for HER2-positive metastatic gastric cancer.

Meanwhile, in September 2025, Daiichi Sankyo and AstraZeneca received priority review from the US Food and Drug Administration for the supplemental biologics license application of Enhertu in combination with pertuzumab, suggesting further expansion of the treatment’s clinical applications may be forthcoming.