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).
| Apr 24, 2024 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Apr 5, 2022 | Original applicationNew indication · Priority review | Approved |
| Jul 22, 2025 | Supplement 3Labeling · Standard review | Approved | |
| Apr 24, 2024 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Nov 17, 2022 | Supplement 1Labeling · Standard review | Approved | |
| Apr 5, 2022 | Original applicationNew indication · Priority review | Approved |
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
