PIK3CA and breast cancer: In May 2019, alpelisib (PIQRAY, Novartis Pharmaceuticals Corporation) was given FDA approval in combination with fulvestrant for postmenopausal women and men with recurrent/metastatic hormone receptor positive HER2-negative breast cancer patients who had a ­phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA) mutation.