AstraZeneca's First-in-Class AKT Inhibitor Capivasertib Approved in China for HR+/HER2- Advanced Breast Cancer

Intelligent Finance APP learned on April 18 that the official website of China's National Medical Products Administration (NMPA) announced the approval of AstraZeneca's (AZN.US) Class 1 innovative drug, Capivasertib, for marketing.The product was approved for marketing by the U.S. FDA in November 2023 (brand name: Truqap) for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.

Screenshot source: NMPA official website

Publicly available information shows that this is a "first-in-class" AKT inhibitor. The drug is suitable for use in combination with fulvestrant for adult patients with locally advanced or metastatic breast cancer that is hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, and accompanied by one or more PIK3CA/AKT1/PTEN alterations. These patients should have experienced disease progression after receiving at least one endocrine therapy in the metastatic setting, or relapsed during adjuvant therapy or within 12 months after completing adjuvant therapy.