Novartis’ Piqray combo becomes first Europe-approved therapy for PIK3CA-mutated advanced breast cancer

pharmafile | July 29, 2020 | News story | Research and Development, Sales and Marketing |  Europe, Novartis, Piqray, breast cancer, pharma 

The European Commission (EC) has awarded its approval for Novartis’ Piqray (alpelisib) to be made available in combination with fulvestrant in the treatment of hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer, it has emerged.

The indication relates both to men and postmenopausal women whose condition features a PIK3CA mutation and who have seen their disease progress after receiving endocrine therapy as monotherapy, making it the first therapy available in Europe for advanced breast cancer patients whose tumours express this particular mutation

The EC came to the decision after considering a previous recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) to approve the combo in this indication.

The Commission also considered Phase 3 data demonstrating that the combo “nearly doubled” progression-free survival compared to fulvestrant alone, as well as the overall rate of patients who saw a 30% reduction in the size of their tumours versus fulvestrant monotherapy.

“Piqray is an important new therapy for HR+/HER2- advanced breast cancer patients whose tumours have a PIK3CA mutation, and we look forward to making it available in countries across Europe,” said Kees Roks, Head Region Europe at Novartis Oncology. “Knowledge of PIK3CA status can better equip doctors as they develop a personalised 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.”

Matt Fellows