Author Interviews, Breast Cancer, Cancer Research, Genetic Research, Novartis / 03.06.2019
Novartis Piqray® Approved for Patients with a PIK3CA Mutation in HR+/HER2- Advanced Breast Cancer
MedicalResearch.com Interview with:
Fabrice André, MD, PhD
Research director and head of INSERM Unit U981
Professor in the Department of Medical Oncology
Institut Gustave Roussy in Villejuif, France
Global SOLAR-1 Principal Investigator.
MedicalResearch.com: What is the background for this study? How does Piqray® differ from other treatments for this type of advanced breast cancer?
- The US Food and Drug Administration (FDA) approved Piqray® (alpelisib, formerly BYL719) 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 after disease progression following an endocrine-based regimen.
- Piqray is the first and only combination treatment with fulvestrant specifically for postmenopausal women, and men, with HR+/HER2- advanced or metastatic breast cancer with a PIK3CA mutation following progression on or after an endocrine-based regimen, bringing a biomarker-driven therapy option to this population for the first time.
- Advanced breast cancer is incurable, and patients with all types need more treatment options. With this approval, physicians can now use an FDA-approved test to determine if their patients’ HR+/HER2- advanced breast cancer has a PIK3CA mutation and may be eligible for treatment with Piqray plus fulvestrant combination therapy.