国家药监局：批准荃科得联合氟维司群用于HR阳性晚期乳腺癌患者

Core Insights - The approval of Truqap® (capivasertib) in combination with fulvestrant for the treatment of adult patients with HR-positive, HER2-negative breast cancer with specific genetic alterations marks a significant advancement in targeted therapy options for this patient population [1][3]. Group 1: Approval and Study Results - The approval is based on positive results from the global phase III CAPItello-291 study, which showed that capivasertib combined with fulvestrant reduced the risk of disease progression or death by 50% in patients with PIK3CA/AKT1/PTEN alterations compared to fulvestrant alone [3]. - In the Chinese cohort, the combination therapy demonstrated a 59% reduction in disease progression or death risk for patients with PIK3CA, AKT1, or PTEN gene alterations compared to fulvestrant monotherapy [3]. Group 2: Breast Cancer Statistics and Treatment Landscape - Breast cancer is the most common malignant tumor among women in China, with HR-positive breast cancer accounting for 70% of cases globally [4]. - Approximately 50% of HR-positive advanced breast cancer patients carry alterations in PIK3CA, AKT1, or PTEN genes, with this figure rising to 57% in the Chinese population [4]. - The presence of these genetic alterations often leads to resistance against standard endocrine therapies, highlighting the need for combination treatment strategies to enhance therapeutic efficacy [4]. Group 3: Expert Commentary - Professor Hu Xichun, a leading researcher in the CAPItello-291 study, emphasized the importance of this approval as it provides a new treatment option for patients with advanced HR-positive breast cancer who have specific genetic alterations, potentially extending survival and improving disease management [5].