China’s National Medical Products Administration (NMPA) has approved AstraZeneca’s (AZ, NASDAQ: AZN) Truqap (capivasertib) for use in combination with fulvestrant to treat patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer. The approval specifically targets patients with one or more PIK3CA/AKT1/PTEN alterations who have been treated with at least one endocrine therapy at the metastatic stage but experienced disease progression, or whose cancer recurred during or within 12 months after completing adjuvant therapy.
Drug Profile and Mechanism
Truqap is a potential first-in-class AKT1/2/3 inhibitor. It received marketing approval in the US in November 2023 for HR+, HER2- advanced or metastatic breast cancer when used in combination with fulvestrant. The drug is also under investigation in clinical trials for prostate cancer.-Fineline Info & Tech
