12 June 2023 - Decision based on CAPItello-291 Phase 3 trial results which showed the combination reduced the risk of disease progression or death by 40% versus Faslodex alone.
AstraZeneca’s new drug application for capivasertib in combination with Faslodex (fulvestrant) has been accepted and granted Priority Review in the US for the treatment of adult patients with hormone receptor positive, human epidermal growth factor receptor 2 negative locally advanced or metastatic breast cancer following recurrence or progression on or after an endocrine-based regimen.