capivasertib

FDA Drug Profile — TRUQAP

Drug Details

Generic Name
capivasertib
Brand Names
TRUQAP
Application Number
NDA218197
Sponsor
AstraZeneca AB
NDC Codes
4
Dosage Forms
TABLET, FILM COATED
Routes
ORAL
Active Ingredients
CAPIVASERTIB

Indications and Usage

1 INDICATIONS AND USAGE TRUQAP, 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 with one or more PIK3CA/AKT1/PTEN -alteration as detected by an FDA-approved test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. TRUQAP is a kinase inhibitor indicated, in combination with fulvestrant 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 with one or more PIK3CA/AKT1/PTEN -alterations as detected by an FDA-approved test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. (1)