AIFA approves personalized breast cancer therapy in Italy

The Italian Medicines Agency (AIFA) has approved the reimbursement of inavolisib in combination with palbociclib and fulvestrant for treating specific types of breast cancer. This personalized therapy is intended for patients with locally advanced or metastatic hormone receptor-positive (HR+), HER2-negative breast cancer that is endocrine-resistant and carries a Pik3Ca gene mutation.

According to Roche, the approval is based on results from the phase 3 Inavo120 study published in the New England Journal of Medicine. The study, involving 325 patients, demonstrated a 57% reduction in the risk of disease progression or death compared to using palbociclib and fulvestrant alone. The data showed that progression-free survival more than doubled, increasing from 7.3 months to 15.0 months. Additionally, the treatment showed a significant benefit in overall survival, with a median of 34.0 months compared to 27.0 months in the control group.