
Japanese pharma Daiichi Sankyo (TSE: 4568) and British partner AstraZeneca (LSE: AZN) said Enhertu (trastuzumab deruxtecan) has been approved in China as a second-line treatment for adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma after one trastuzumab-based regimen.
The companies said China’s National Medical Products Administration decision makes Enhertu the first and only HER2-directed antibody-drug conjugate approved in the country for this second-line setting, and marks the drug’s sixth Chinese approval across three tumor types in under three years.
Daiichi Sankyo said the Phase III DESTINY-Gastric04 trial met its primary endpoint, showing a statistically significant overall survival benefit versus ramucirumab plus paclitaxel. Median overall survival was 14.7 months for Enhertu versus 11.4 months for the comparator regimen, the company said.
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