Posted by Michael Wonder on 29 Jul 2020
Novartis receives Piqray approval in Europe – the first and only targeted medicine for HR+/HER2- advanced breast cancer with a PIK3CA mutation
29 July 2020 - Approval based on SOLAR-1 Phase III trial showing Piqray plus fulvestrant nearly doubled median PFS (11.0 vs. 5.7 months), compared to fulvestrant alone.
Novartis today announced the European Commission has approved Piqray (alpelisib) in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy.
Piqray is the first and only treatment specifically approved for people with advanced breast cancer whose tumours harbor a PIK3CA mutation, which stimulates tumour growth and is associated with poor response to therapy.
