Treats Grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate…. NDA 218784, held by Servier. Vorasidenib.
As of Nov 13, 2026, NDA 218784 (Voranigo), held by Servier, was first approved by FDA on Aug 6, 2024, with 2 approved supplements and 0 published complete response letters.
VORANIGO is indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutation, as detected by an FDA-approved test, following surgery including biopsy, sub-total resection, or gross total resection.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 6, 2024 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Voranigo10MG · tablet;oral | Vorasidenib | RxReference drug |
| Voranigo40MG · tablet;oral | Vorasidenib | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 10, 2026 | Supplement 4Labeling · Standard review | Approved | |
| Apr 8, 2025 | Supplement 2Labeling · Standard review | Approved | |
| Aug 6, 2024 | Original applicationNew molecular entity · 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
