FDA Approves Piqray-Faslodex Combo for Some Patients with Advanced Breast Cancer

FDA Approves Piqray-Faslodex Combo for Some Patients with Advanced Breast Cancer
Breast cancer patients in the U.S. who are receptor positive (HR+), human epidermal growth factor receptor-2 negative (HER2-), and have mutated PIK3CA can now be treated with Novartis' Piqray (alpelisib) in combination with Faslodex (fulvestrant). The U.S. Food and Drug Administration (FDA) has approved the use of this combo therapy to treat this specific population of patients with advanced or metastatic breast cancer, including postmenopausal women and men who have progressed on or after an endocrine-based treatment regimen. "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," Susanne Schaffert, PhD, CEO, Novartis Oncology, said in a press release. Approximately 40% of patients living with HR+/HER2- breast cancer have a mutation in the PIK3CA gene, making it the most commonly mutated gene in this group of patients. Patients with PIK3CA mutations are more likely to experience higher tumor growth, be more resistant to endocrine treatment, and have a poor overall prognosis. Piqray, formerly known as BYL719, was designed to
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