Novartis receives Piqray approval in Europe – the first and only targeted medicine for HR+/HER2- advanced breast cancer with a PIK3CA mutation

Piqray (alpelisib) is the only treatment approved specifically to address PIK3CA mutation, underscoring Novartis commitment to reimagining cancer care

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


Basel, July 29, 2020 — Novartis today announced the European Commission (EC) 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 tumors harbor a PIK3CA mutation, which stimulates tumor growth and is associated with poor response to therapy.

“Piqray is an important new therapy for HR+/HER2- advanced breast cancer patients whose tumors have a PIK3CA mutation, and we look forward to making it available in countries across Europe,” said Kees Roks, Head Region Europe, Novartis Oncology. “Knowledge of PIK3CA status can better equip doctors as they develop a personalized upfront treatment plan for patients. Piqray offers new hope for advanced breast cancer patients with a PIK3CA mutation, who typically face a worse overall prognosis.”

This approval follows a positive opinion granted in May by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based on the Phase III SOLAR-1 trial showing that Piqray nearly doubled median progression-free survival (PFS) compared to fulvestrant alone1,2. Overall response rate, an indicator of the proportion of patients who experience at least a 30% reduction in overall tumor size (in patients with measurable disease), was more than doubled when Piqray was added to fulvestrant compared to fulvestrant alone1,2. Read more about the positive CHMP opinion and the SOLAR-1 clinical trial results here.

Patients with HR+/HER2- advanced breast cancer should be selected for treatment with Piqray based on the presence of a PIK3CA mutation in tumor or plasma specimens, using a validated test. If a mutation is not detected in a plasma specimen, tumor tissue should be tested if available.