Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that ER positive, HER2-negative, PIK3CA somatic variants, PR positive status confers therapeutic sensitivity to Alpelisib, Fulvestrant in patients with Invasive Breast Carcinoma.
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.
This statement is based on a regulatory approval from the Food and Drug Administration:
PIQRAY is a kinase inhibitor indicated in combination with fulvestrant for the treatment of adults 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.