AstraZeneca's Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been recommended for approval in the European Union (EU) for the treatment of adult patients with estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1, or PTEN-alterations following recurrence or progression on or after an endocrine-based regimen.The recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) was based on the results of the CAPItello-291 trial, which showed that the Truqap combination reduced the risk of disease progression or death by 50% versus Faslodex standard of care in a biomarker-altered population.AstraZeneca noted that regulatory applications are currently under review in China and several other countries, and similar indications for Truqap in combination with Faslodex are already approved in Japan, the US and several other countries based on results from the CAPItello-291 trial..

阿斯利康的Truqap（capivasertib）联合Faslodex（氟维司群）已被推荐用于欧盟（EU）批准用于治疗雌激素受体（ER）阳性，HER2阴性局部晚期或转移性乳腺癌的成年患者，其中一种或多种PIK3CA，AKT1或PTEN改变是在基于内分泌的方案上或之后复发或进展的。欧洲药品管理局（EMA）人类使用药品委员会（CHMP）的建议是基于CAPItello-291试验的结果，该试验表明Truqap组合降低了疾病进展或死亡的风险。与生物标志物改变人群中的Faslodex标准护理相比，降低了50%。阿斯利康指出，中国和其他几个国家目前正在审查监管申请，根据CAPItello-291试验的结果，日本、美国和其他几个国家已经批准了Truqap联合Faslodex的类似适应症。。