PIQRAY® is approved and now available in Canada as the first and only treatment specifically for patients with a PIK3CA mutation in HR-positive, HER2-negative advanced breast cancer
Approval is based on results from SOLAR-1, where PIQRAY® in combination with fulvestrant nearly doubled median progression-free survival (PFS) compared to fulvestrant alone.
Novartis Pharmaceuticals Canada Inc. (Novartis) is pleased to announce that PIQRAY® (alpelisib) is approved and now available in Canada. PIQRAY® in combination with fulvestrant is indicated 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 after disease progression following an endocrine-based regimen. This approval marks the first-ever treatment specifically for HR-positive, HER2-negative metastatic breast cancer with a PIK3CA mutation and is based on results from the pivotal SOLAR-1 clinical trial, which included ten Canadian trial sites and ten Canadian investigators.