FDA approves Novartis Piqray? - the first and only treatment specifically for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer
- Piqray?(alpelisib, formerly BYL719)?plus fulvestrant nearly doubled median PFS (11.0 vs 5.7 months) in HR+/HER2- advanced breast cancer patients with a PIK3CA mutation compared to fulvestrant alone in the SOLAR-1 clinical trial[1],[2],[3],[4]
- ~40% of?HR+/HER2- advanced breast cancer patients may face worse disease prognosis due to presence of PIK3CA mutations in their tumors[5],[6],[7],[8],[9]
- Piqray was the first new drug application approved under the FDA Oncology Center of Excellence Real-Time Oncology Review pilot program