The Food and Drug Administration has approved Piqray (alpelisib) tablets to treat men and postmenopausal women whose advanced breast cancer is hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative and PIK3CA-mutated.
Piqray is to be used in combination with the FDA-approved endocrine therapy fulvestrant. The PIK3CA-mutated, advanced or metastatic breast cancer (as detected by an FDA-approved test) is indicated following progression on or after an endocrine-based regimen.
PIK3CA mutations are common, occurring in 20-30% of all cases of breast cancer and 40% of HR+/HER2 breast cancer cases. PIK3CA mutations are associated with tumor growth, resistance to endocrine treatment and a poor overall prognosis. Piqray works by inhibiting the PI3K pathway.
The FDA also approved a companion diagnostic test, therascreen PIK3CA RGQ PCR Kit, to detect the PIK3CA mutation in a tissue and/or a liquid biopsy.
The PIK3CA mutation occurs at random (is sporadic) and is not hereditary like the BRCA1/2 mutation. In addition to breast cancer, PIK3CA mutations occur in endometrial and colon cancers.
Research involved a randomized trial (Phase III trial, SOLAR-1) of 572 men and postmenopausal women with HR-positive, HER2-negative, metastatic breast cancer whose cancer had progressed while they were taking an aromatase inhibitor (AI) or after they had completed AI treatment. Adding Piqray to fulvestrant significantly prolonged progression- free survival (median of 11 months vs. 5.7 months) in patients whose tumors had a PIK3CA mutation.
There are a host of side-effects, however.
This “approval is expected to change the way we practice medicine in advanced breast cancer. For the first time, physicians can test for PIK3CA biomarkers and develop a treatment plan based on the genomic profile of a patient’s cancer,” said Fabrice André, MD, PhD, research director and head of INSERM Unit U981, professor in the Department of Medical Oncology at Institut Gustave Roussy in Villejuif, France, and global SOLAR-1 principal investigator.
The manufacturer, Novartis, is based in Switzerland.