In May 2019, the FDA approved Piqray (alpelisib; from Novartis) tablets, a PIK3CA inhibitor, in combination with Faslodex (fulvestrant; from AstraZeneca), an endocrine therapy, for the treatment of postmenopausal women, and men, with HR-positive, HER2-negative advanced or metastatic breast cancer and the genetic alteration, PIK3CA mutation, as detected by an FDA-approved test approved on the same day, the therascreen PIK3CA RGQ PCR Kit.
“Piqray is the first PI3K inhibitor to demonstrate a clinically meaningful benefit in treating patients with this type of breast cancer,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence.
The approval of Piqray was based on a clinical trial with 572 postmenopausal women, and men, with HR-positive, HER2-negative, advanced or metastatic breast cancer whose cancer had progressed during or after an endocrine-based therapy. In patients with a PIK3CA mutation, Piqray plus Faslodex treatment resulted in an average of 11 months without disease progression versus 5.7 months with Faslodex alone.
Some of the side effects associated with Piqray are elevated blood sugar, diarrhea, rash, nausea, fatigue, low red blood cell count, decreased appetite, inflammation in the mouth, vomiting, weight loss, low calcium levels, a rare blood-clotting disorder, and hair loss.
