Trastuzumab Deruxtecan Wins Tumor-Agnostic Approval in China
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China has approved a tumor-agnostic indication for trastuzumab deruxtecan, the HER2-directed antibody-drug conjugate developed by Daiichi Sankyo and AstraZeneca. The approval covers adults with unresectable or metastatic HER2 IHC 3+ solid tumors who have received prior treatment or have no satisfactory alternative options, and follows priority review by the Center for Drug Evaluation. Since its first approval in China in December 2019, the drug has expanded across breast cancer, gastric cancer and non-small cell lung cancer, among other tumor types. The new indication broadens its use beyond specific tumor types to any qualifying HER2-positive solid tumor. Open questions include uptake in the tumor-agnostic setting and how the approval shapes the competitive landscape for HER2-targeted therapies in China.
Written by a model from the reports · updated 47 min ago
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- mp.weixin.qq.comPickDaiichi Sankyo and AstraZeneca's Trastuzumab Deruxtecan Wins Tumor-Agnostic Indication in China
On October 22, Daiichi Sankyo and AstraZeneca's trastuzumab deruxtecan received approval in China for a new tumor-agnostic indication: adults with unresectable or metastatic HER2 IHC 3+ solid tumors who have received prior treatment or have no satisfactory alternative options. The CDE had granted the indication priority review. Since its first approval in December 2019, the drug has expanded across breast cancer, gastric cancer and non-small cell lung cancer, among other tumor types.
- mp.weixin.qq.comEnhertu Wins China's First Pan-Tumor HER2 ADC Indication for Pretreated HER2-Positive Metastatic Solid Tumors
AstraZeneca announced that Enhertu (trastuzumab deruxtecan) received conditional approval from the NMPA on October 20, 2026, for previously treated HER2-positive (IHC 3+) unresectable or metastatic solid tumors. It becomes the first HER2-targeted ADC approved for a pan-tumor indication in China.
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