Piqray (alpelisib) received approval from the European Commission 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 sponsored by Novartis.
Piqray is the first and only treatment specifically approved for people with advanced breast cancer whose tumors harbor a PIK3CA mutation, which stimulates tumor growth and is associated with poor response to therapy.
This approval follows a positive opinion granted in May by the Committee for Medicinal Products for Human Use of the European Medicines Agency based on the phase III SOLAR-1 trial showing that Piqray nearly doubled median progression-free survival compared to fulvestrant alone.
Overall response rate was more than doubled when Piqray was added to fulvestrant compared to fulvestrant alone.
