Novartis’ Piqray Approved in Canada for Specific Breast Cancer

Health Canada has approved Novartis’ Piqray (alpelisib) to be used in combination with fulvestrant for the treatment of HR-positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer after disease progression following an endocrine-based regimen.

The approval was based on results of a phase 3 trial in which Piqray plus fulvestrant improved progression-free survival compared to fulvestrant alone.

Piqray is the first treatment specifically for HR-positive, HER-2 negative breast cancer with a PIK3CA mutation. The FDA approved the drug for this indication in May 2019.