INDICATION

VORANIGO (40 mg tablets) 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.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hepatotoxicity: VORANIGO can cause hepatic transaminase elevations, which can lead to hepatic failure, hepatic necrosis, and autoimmune hepatitis. Monitor liver laboratory tests (AST, ALT, GGT, total bilirubin, and alkaline phosphatase) prior to the start of VORANIGO, every 2 weeks during the first 2 months of treatment, then monthly for the first 2 years of treatment, and as clinically indicated, with more frequent testing in patients who develop transaminase elevations. Reduce the dose, withhold, or permanently discontinue VORANIGO based on severity.

Embryo-Fetal Toxicity: Based on findings from animal studies, VORANIGO can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective nonhormonal contraception during treatment with VORANIGO and for 3 months after the last dose, since VORANIGO can render some hormonal contraceptives ineffective. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with VORANIGO and for 3 months after the last dose.

ADVERSE REACTIONS

The most common (≥15%) adverse reactions included fatigue, headache, COVID-19, musculoskeletal pain, diarrhea, nausea, and seizure. Grade 3 or 4 (≥2%) laboratory abnormalities were ALT increased, AST increased, GGT increased, and neutrophils decreased.

DRUG INTERACTIONS

Avoid concomitant use of VORANIGO with strong and moderate CYP1A2 inhibitors. Avoid concomitant use with moderate CYP1A2 inducers and smoking tobacco. Avoid concomitant use with CYP3A substrates, where a minimal concentration change can reduce efficacy. If concomitant use of hormonal contraception cannot be avoided, use nonhormonal contraception methods.

LACTATION

Advise women not to breastfeed during VORANIGO treatment and for 2 months after the last dose.

IMPAIRED FERTILITY

VORANIGO may impair fertility of females and males of reproductive potential.

Please see Full Prescribing Information.

BIRC, blinded independent review committee; HR, hazard ratio; mIDH; mutated IDH; PFS, progression-free survival; RANO-LGG, Response Assessment in Neuro-Oncology for Low Grade Glioma.

^aVORANIGO was studied in the INDIGO trial: a phase 3, randomized, multicenter, double-blind, placebo-controlled trial for patients ≥12 years of age with Grade 2 mIDH1/2 astrocytoma or oligodendroglioma (N=331).^3,4

^bPFS is defined as the time from the date of randomization to the date of the first documented disease progression or death from any cause.⁴ PFS was evaluated by a BIRC per modified RANO-LGG criteria.³ The RANO criteria for LGGs define progressive disease as either a radiographic disease response (a ≥25% increase in the sum of perpendicular diameters of T2-weighted or T2-weighted fluid-attenuated inversion recovery hyperintense non-enhancing lesions), or the presence of a new lesion as a newly measurable or increased enhancement.⁴

^cThe 95% CI for the hazard ratio is 0.27 to 0.56. Stratified Cox proportional hazard model, stratified by 1p/19q status and baseline tumor size.³

^dBased on one-sided stratified log-rank test compared to the pre-specified α of 0.000359 (one-sided).³

References: 1. Bhatia A, Moreno R, Reiner AS, et al. Tumor volume growth rates and doubling times during active surveillance of IDH-mutant low-grade glioma. Clin Cancer Res. 2024;30(1):106-115. doi:10.1158/1078-0432.CCR-23-1180 2. Hervey-Jumper SL, Zhang Y, Phillips JJ, et al. Interactive effects of molecular, therapeutic, and patient factors on outcome of diffuse low-grade glioma. J Clin Oncol. 2023;41(11):2029-2042. doi:10.1200/JCO.21.02929 3. Voranigo. Package insert. Servier Pharmaceuticals LLC; 2025. 4. Mellinghoff IK, van den Bent MJ, Blumenthal DT, et al. Vorasidenib in IDH1- or IDH2-mutant low-grade glioma. N Engl J Med. 2023;389(7):589-601. doi:10.1056/NEJMoa2304194

© 2025 Servier Pharmaceuticals LLC. Boston, MA 02210. Customer Service: 1-800-807-6124.

Servier and the Servier Logo are registered trademarks of LES LABORATOIRES SERVIER.

VORANIGO is a registered trademark of SERVIER PHARMACEUTICALS LLC, a wholly owned, indirect subsidiary of LES LABORATOIRES SERVIER.

US-03262 v2  08/2025