金吾财讯 | 9月18日消息，欧洲药品管理局（EMA）人用药品委员会（CHMP）出具积极意见，推荐批准由第一三共与阿斯利康（AZN）联合开发的ADC药物Enhertu®（trastuzumab deruxtecan），用于新辅助治疗后仍有残留浸润性病灶的高危HER2阳性早期乳腺癌成年患者的辅助治疗。该推荐基于DESTINY-Breast05III期试验的数据。结果显示，与现有标准疗法T-DM1相比，Enhertu将患者的浸润性疾病复发或死亡风险大幅降低了53%（HR=0.47），三年无浸润性疾病生存（IDFS）率达到92.4%。目前该意见已提交欧盟委员会进行最终上市许可审批，若顺利获批，Enhertu®有望重塑欧洲早期乳腺癌术后治疗标准。
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