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Treats severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS). NDA 218466, held by Novartis. Alpelisib.
As of Nov 13, 2026, NDA 218466 (Vijoice), held by Novartis, was first approved by FDA on Apr 24, 2024, with 1 approved supplement and 0 published complete response letters.
First approved: Apr 24, 2024
Review: Standard
Supplements approved: 1
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
VIJOICE is indicated for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
