Posted by Michael Wonder on 16 Aug 2020
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
13 August 2020 - Approval is based on results from SOLAR-1, where Piqray in combination with fulvestrant nearly doubled median progression-free survival compared to fulvestrant alone.
Novartis Pharmaceuticals Canada 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.
