The US Food and Drug Administration (FDA) has approved alpelisib tablets (Piqray, Novartis), to be used together with the FDA-approved endocrine therapy fluvestrant, for the treatment of PIK3CA-mutated, advanced or metastatic breast cancer.
The treatment is applicable in postmenopausal women, and men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, breast cancer following progression on or after an endocrine-based regimen, according to an FDA news release.
A “companion” diagnostic test, therascreen PIK3CA RGQ PCR Kit (QIAGEN Manchester), was also approved for detection of the PIK3CA mutation in a tissue biopsy and/or a liquid biopsy.
Patients who get a negative result on the therascreen test on a liquid biopsy should have PIK3CA mutation testing conducted on a tumor biopsy.
The FDA’s approval follows consideration of efficacy data from the SOLAR-1 trial, a randomized trial that included 572 postmenopausal women and men with HR-positive, HER2-negative, advanced or metastatic breast cancer whose cancer had advanced while or after being given an aromatase inhibitor.
The study found that the addition of alpelisib to fulvestrant significantly prolonged progression-free survival (median of 11 months vs 5.7 months) in those whose tumors had a PIK3CA mutation.
“Piqray is the first PI3K inhibitor to demonstrate a clinically meaningful benefit in treating patients with this type of breast cancer. The ability to target treatment to a patient’s specific genetic mutation or biomarker is becoming increasingly common in cancer treatment, and companion diagnostic tests assist oncologists in selecting patients who may benefit from these targeted treatments,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in the news release.