FDA approves alpelisib for PIK3CA-related overgrowth spectrum
Posted April 6, 2022
On April 5, 2022, the Food and Drug Administration granted accelerated approval to alpelisib (Vijoice, Novartis Pharmaceuticals) for adult and pediatric patients two years of age and older with severe manifestations of PIK3CA-related overgrowth spectrum (PROS) who require systemic therapy. Efficacy was evaluated using real-world data from EPIK-P1 (NCT04285723), a single-arm clinical study in patients...