The FDA has approved Novartis’ Piqray (alpelisib) tablets, a kinase inhibitor to be used in combination with the endocrine therapy fulvestrant (Faslodex) to treat postmenopausal women, and men, with HR-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer.

In the Phase 3 SOLAR-1 study, 341 patients were enrolled with a PIK3CA mutation. Results showed that Piqray + fulvestrant, when compared to placebo + fulvestrant, significantly prolonged progression-free survival (PFS, median of 11 months vs. 5.7 months, respectively) in patients whose tumors had a PIK3CA mutation.

No PFS benefit was observed in patients whose tumors did not have a PIK3CA tissue mutation.

Common side effects include high blood sugar levels, elevated creatinine, diarrhea, rash, and hair loss, among others. Severe cutaneous reactions may also occur.

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