阿斯利康(AZN.US)乳腺癌1类创新药在中国获批

智通财经
18 Apr

智通财经APP获悉,4月18日,中国国家药监局(NMPA)官网最新公示,批准阿斯利康(AZN.US)的1类创新药卡匹色替片(capivasertib)上市。该产品已于2023年11月获美国FDA批准上市(商品名:Truqap),用于治疗激素受体(HR)阳性、人表皮生长因子受体2(HER2)阴性的晚期或转移性乳腺癌成年患者。

截图来源:NMPA官网

公开资料显示,这是一款“first-in-class”AKT抑制剂。该药适用于联合氟维司群用于转移性阶段至少接受过一种内分泌治疗后疾病进展,或在辅助治疗期间或完成辅助治疗后12个月内复发的激素受体(HR)阳性、人表皮生长因子受体2(HER2)阴性且伴有一种或多种PIK3CA/AKT1/PTEN改变的局部晚期或转移性乳腺癌成人患者。

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