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mp.weixin.qq.com· 第一三共中国·· 8 hours agoPickScore89

Trastuzumab Deruxtecan Gains Conditional Tumor-Agnostic HER2-Positive Approval in China

优赫得®新适应症在中国获批成为首个且唯一*用于既往经治HER2阳性转移性实体瘤患者的泛瘤种HER2靶向抗体偶联药物

In brief

Daiichi Sankyo's trastuzumab deruxtecan (Enhertu) has been approved in China for adult patients with unresectable or metastatic solid tumors expressing HER2 IHC 3+ who have received prior treatment or have no satisfactory alternative options. The approval, granted conditionally by the NMPA, covers a tumor-agnostic indication.

Why it matters

Four phase II studies provide cross-tumor ORR, survival and ILD safety data for weighing benefit, risk and evidence limits.

Source: mp.weixin.qq.com · mp.weixin.qq.com

CBACBA Frontier Insights (CFI)Chinese Biopharmaceutical Association (CBA)www.cba-usa.org