AstraZeneca Announces FDA Approval of Capivasertib, a First-in-Class AKT Inhibitor, for HR+/HER2- Advanced Breast Cancer

Intelligent Finance APP learned on November 16 that the FDA approved AstraZeneca's (AZN.US) AKT inhibitor Capivasertib for marketing, used to treat hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer patients whose disease has recurred or progressed during or after receiving endocrine-based therapy. This also means that the AKT target has finally seen the light after more than 40 years of arduous exploration.

It is reported that the FDA's approval this time was based on positive data from a Phase III study, code-named CAPItello-291. This study is a global, multicenter, double-blind, randomized Phase III clinical trial, which enrolled a total of 708 patients. It aims to evaluate the efficacy and safety of capivasertib plus fulvestrant versus placebo plus fulvestrant in patients with HR+/HER2- advanced breast cancer who experienced disease recurrence or progression during or after treatment with aromatase inhibitors (AI).