The FDA has approved Novartis’ PI3K inhibitor Piqray (alpelisib formerly BYL719) alongside fulvestrant for advanced breast cancer via the FDA’s new Real-Time Oncology Review pilot programme. It is the first and only drug to be approved by the FDA for patients with hormone receptor-positive, HER2- negative breast cancer with a PIK3CA mutation. PIK3CA is the most commonly mutated gene in HR+/HER2- breast cancer, seen in approximately 40% of patients, and tends to make them less responsive to standard treatment with hormone-based therapies.
“Novartis gets FDA approval for Piqray“
In the SOLAR-1 study, the combination of Piqray and fulvestrant improved median progression-free survival to 11 months and overall response rate to 38% versus 5.7 months and 16% respectively with fulvestrant alone. Fabrice André of the Institut Gustave Roussy in France, who led the SOLAR-1 trial, said: “Today's approval is expected to change the way we practice medicine in advanced breast cancer. For the first time, physicians can test for PIK3CA biomarkers and develop a treatment plan based on the genomic profile of a patient's cancer.”