智通财经APP获悉，近日，FDA官网宣布将在2026年4月30日召开肿瘤药物咨询委员会(ODAC)会议，就阿斯利康(AZN.US)递交的两项上市申请展开讨论：①口服SERD药物Camizestrant联合CDK4/6抑制剂一线治疗存在ESR1突变的局部晚期或转移性HR+/HER2-乳腺癌②AKT抑制剂Capivasertib联合阿比特龙治疗存在PTEN缺陷的转移性激素敏感性前列腺癌(mHSPC)。
Camizestrant是阿斯利康自主研发的下一代口服选择性雌激素受体降解剂(SERD)，已在美国、欧洲和日本申报上市。
Capivasertib是阿斯利康自主研发的一款AKT1/2/3高效选择性抑制剂。AKT信号通路的激活，包括PIK3CA、AKT1和PTEN的改变，可出现在许多HR+/HER2-的晚期乳腺癌患者中，但也可能出现在没有这些基因改变的患者中。AKT信号通路与内分泌治疗耐药的发生有关。
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