FDA approves new drug to treat advanced breast cancer

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.

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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.


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