Novartis’ Piqray (alpelisib) has been approved by the US Food and Drug Administration (FDA) in combination with fulvestrant for the treatment of postmenopausal women and men with HR+ and HER2- PIK3CA-mutated, advanced or metastatic breast cancer.

The FDA approval is based on a Phase III trial, SOLAR-1, in which the combination nearly doubled median progression free survival (PFS) from 5.7 months to 11 months in HR+/HER2- advanced breast cancer patients with a PIK3CA mutation.

PIK3CA is the most commonly mutated gene in HR+/HER2- breast cancer, with approximately 40% of patients living with the mutation. It is unfortunately associated with tumor growth, resistance to endocrine treatment and a poor overall prognosis.

Piqray works by inhibiting the PI3K pathway, predominantly the PI3K-alpha isoform, to address the effect of PIK3CA mutations and may help overcome endocrine resistance in HR+ advanced breast cancer.

"The FDA approval of Piqray, which was discovered at the Novartis Institutes for BioMedical Research, marks the first ever treatment specifically for HR+/HER2- advanced breast cancer with a PIK3CA mutation. We are proud to offer a new treatment option that specifically addresses the needs of the patients living with this mutation," said Susanne Schaffert, chief executive, Novartis Oncology.

"We are grateful to our researchers' bold and unrelenting pursuit of a first-in-class treatment for this incurable disease, and to the patients, investigators and administrators who participated in the clinical trials leading to this remarkable milestone."

The treatment is the first new drug application approved under the FDA Oncology Center of Excellence Real-Time Oncology Review pilot program.

The FDA also approved the companion diagnostic test, therascreen PIK3CA RGQ PCR Kit, to detect the PIK3CA mutation in a tissue or a liquid biopsy.