Novartis’ Vijoice (alpelisib) Receives the US FDA’s Approval for the Treatment of PIK3CA-Related Overgrowth Spectrum
Shots:
- The US FDA approval was based on RWE from the (EPIK-P1) study evaluating Vijoice in adult & pediatric patients aged ≥2yrs. with PIK3CA-related overgrowth spectrum
- The results showed a 74% reduction in target lesion volume with a mean reduction of 13.7%, 27% with a confirmed response with ≥20% reduction in PROS target lesion volume @24wk., no patients experienced disease progression at the time of primary analysis
- Additionally, improvements in pain (90%), fatigue (76%), vascular malformation (79%), limb asymmetry (69%) & disseminated intravascular coagulation (55%). The company provides a patient support program including assistance to access medication, financial resources & continued education
Ref: Novartis | Image: Novartis
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