FDA approves Novartis Piqray® - the first and only treatment specifically for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer
Novartis today announced the US Food and Drug Administration (FDA) 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-), PIK3CA-mutated, advanced or metastatic breast cancer, as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
FDA approval is based on results of the Phase III trial, SOLAR-1, that showed Piqray plus fulvestrant nearly doubled median progression-free survival (PFS) compared to fulvestrant alone in HR+/HER2- advanced breast cancer patients with a PIK3CA mutation (median PFS 11.0 months vs 5.7 months; HR=0.65, 95% CI: 0.50-0.85; p<0.001). Piqray provided consistent PFS results across pre-specified subgroups, including among patients previously treated with a CDK4/6 inhibitor
“Piqray is the first PI3K inhibitor to show clinically significant efficacy in the treatment of this type of breast cancer. Developing targeted therapies based on specific genes and biomarkers carried by patients is becoming more common in cancer treatment. Dr. Richard Padzur, Director of the FDA Center for Excellence in Cancer, said: "This drug is also the first innovative drug approved by the RTOR pilot program."