By PPN News Staff
The FDA approved alpelisib (Piqray, Novartis) tablets, to be used with the FDA-approved endocrine therapy fulvestrant (Faslodex, AstraZeneca) to treat postmenopausal women, and men, 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.
The FDA also approved the companion diagnostic test,