mp.weixin.qq.com· 丁香园 Insight 数据库·· 4 hours agoPickScore83
Daiichi Sankyo and AstraZeneca's Trastuzumab Deruxtecan Wins Tumor-Agnostic Indication in China
不限癌种！第一三共/阿斯利康重磅 ADC 新适应症在中国获批上市
In brief
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.
Why it matters
Trastuzumab deruxtecan's HER2 IHC 3+ tumor-agnostic approval in China allows comparison of review timing and covered populations with analogous global approvals.
Source: mp.weixin.qq.com · mp.weixin.qq.com