Indications of Capivasertib

Capivasertib in combination with fulvestrant is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer, who have one or more PIK3CA/AKT1/PTEN gene mutations confirmed by a test method approved by the U.S. Food and Drug Administration (FDA) and meet the following criteria: the patients have experienced disease progression after receiving at least one endocrine therapy regimen during the metastatic disease stage, or have had a recurrence within 12 months after completion of adjuvant therapy.

from FDA，2024.09