乳腺癌新辅助治疗 阿斯利康(AZN.US)/第一三共HER2 ADC新适应症拟纳入优先审评

智通财经
Jul 25

智通财经APP获悉,7月25日,国家药品监督管理局(NMPA)药品审评中心(CDE)官网显示,第一三共与阿斯利康(AZN.US)共同开发的德曲妥珠单抗被纳入拟优先审评行列,用于HER2阳性乳腺癌患者新辅助治疗。

医药魔方数据库显示,德曲妥珠单抗已在我国获批了4项适应症,其中两项是乳腺癌相关适应症,分别为:适用于治疗既往接受过一种或多种抗HER2治疗方案的不可切除或转移性HER2阳性乳腺癌成年患者、用于治疗既往在转移性疾病阶段接受过至少一种系统治疗的,或在辅助化疗期间或完成辅助化疗之后6个月内复发的,不可切除或转移性HER2低表达(IHC 1+或IHC 2+/ISH-)成人乳腺癌患者。

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