Expansion of treatment indications in China On January 22, 2026, China’s National Medical Products Administration (NMPA) officially approved Enhertu (trastuzumab deruxtecan) for the treatment of adults with HER2-positive locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. This approval establishes the drug as a second-line treatment option for patients who have previously undergone a trastuzumab-based regimen.
Clinical evidence and efficacy The regulatory green light was supported by data from the Phase III DESTINY-Gastric04 clinical trial. Key findings from the study include:
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Mortality reduction: The therapy demonstrated a 30% reduction in the risk of death compared to standard chemotherapy regimens.
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Survival benefit: Median overall survival reached 14.7 months, compared to 11.4 months in the control group.
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Disease response: A confirmed objective response rate (ORR) of 44.3% was observed, including several instances of complete remission.
Impact on oncology practice This marks the sixth indication approved for Enhertu in China in less than three years. As a next-generation antibody-drug conjugate (ADC), this therapy is recognized for shifting the treatment paradigm from conventional chemotherapy toward precision medicine, effectively addressing a critical gap in targeted options for gastric cancer patients in the region.
Source: https://www.pharmaceutical-technology.com/news/daiichi-sankyo-astrazenecas-enhertu-approval/?cf-view