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