Therapeutic Response

ER positive, HER2-negative, PIK3CA somatic variants, and PR positive status confers therapeutic sensitivity to Alpelisib in combination with Fulvestrant in patients with Invasive Breast Carcinoma.

Statements

Source and description

Piqray (alpelisib) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to alpelisib in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer, as detected by an FDA-approved test, following progression on or after an endocrine-based regimen.