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First PI3K Inhibitor Approved for Breast Cancer

Data Show Drug Significantly Prolongs Survival

The FDA has approved alpelisib tablets (Piqray, Novartis), used in combination with fulvestrant, for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen.

In addition, the agency approved the therascreen PIK3CA RGQ PCR Kit (QIAGEN Manchester, Ltd.), a companion diagnostic test for detecting the PIK3CA mutation in a tissue and/or liquid biopsy.

Alpelisib’s efficacy was studied in the randomized SOLAR-1 study of 572 postmenopausal women and men with HR-positive, HER2-negative, advanced or metastatic breast cancer whose cancer had progressed while on or after receiving an aromatase inhibitor. Results showed that adding alpelisib to fulvestrant significantly prolonged progression-free survival (median, 11 months vs. 5.7 months) in patients whose tumors had a PIK3CA mutation.

Common side effects include high blood-sugar levels, creatinine increase, diarrhea, rash, decreased lymphocyte count, elevated liver enzymes, nausea, fatigue, low red-blood cell count, increased lipase, decreased appetite, stomatitis, and vomiting, among others.

The FDA granted alpelisib a priority review designation.

Source: FDA, May 24, 2019

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Decision supported by data from more than 4,000 patients