Posted by Michael Wonder on 06 Apr 2022
FDA approves Novartis Vijoice (alpelisib) as first and only treatment for select patients with PIK3CA related overgrowth spectrum
6 April 2022 - Approval based on real world data from EPIK-P1 study, which showed patients treated with Vijoice experienced reduction in the size of PROS lesions and improvement of PROS-related signs and symptoms.
Novartis today announced that the U.S. FDA granted accelerated approval to Vijoice (alpelisib) for the treatment of adult and paediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy.
