卡匹色替联合疗法国内获批上市，治疗特定生物标志物改变的乳腺癌

Core Insights - AstraZeneca announced the approval of Capivasertib (brand name: QianKede) in China for the treatment of locally advanced or metastatic breast cancer in adult patients with HR-positive, HER2-negative tumors and specific genetic alterations [1][2] - This approval is based on positive results from the global Phase III CAPItello-291 study, which showed that Capivasertib combined with Fulvestrant significantly reduces the risk of disease progression or death in patients with PIK3CA/AKT1/PTEN alterations [1][2] Summary by Sections - Approval Details - Capivasertib is the first and only AKT inhibitor approved in China for the specified indication [1] - The approval follows positive results from the CAPItello-291 study published in the New England Journal of Medicine [1] - Clinical Study Results - In the global population, 69% of patients had previously received CDK4/6 inhibitors [2] - Capivasertib combined with Fulvestrant reduced the risk of disease progression or death by 50% compared to Fulvestrant alone in patients with relevant biomarkers [2] - In the Chinese cohort, the combination therapy reduced the risk by 59% for patients with PIK3CA, AKT1, or PTEN alterations [2] - Clinical Implications - The approval provides a new treatment option for patients with advanced HR-positive breast cancer who have developed resistance to initial endocrine therapy [2] - It highlights the importance of precision medicine in breast cancer treatment [2]