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Voranigo® (vorasidenib) tablets logo

In patients with Grade 2 mIDH astrocytoma or oligodendroglioma

Halt progression with precision.

VORANIGO® (vorasidenib)—Proven to significantly extend progression-free survival (PFS)1,2

Primary analysis: 61% reduced risk of disease progression or death with VORANIGO vs placebo (HR=0.39; 95% CI, 0.27-0.56; P<0.0001)1

VORASIDENIB IS

NCCN

PREFERRED

National Comprehensive Cancer Network® (NCCN®) includes vorasidenib (VORANIGO) in guidance for treating Grade 2 mIDH glioma3

Learn more

WITH 6 MONTHS OF ADDITIONAL DATA

65 percent.

reduced risk of disease progression

PFS extended analysis2,a:

  • 65% reduced risk of disease progression or death with VORANIGO vs placebo (HR=0.35; 95% CI, 0.25-0.49)

  • Median PFS was not reached for VORANIGO (95% CI, 22.1-NE) vs 11.4 months for placebo (95% CI, 11.1-13.9)

  • The extended analysis for PFS was not controlled for multiplicity

aThe extended analysis includes an additional 6 months of data from the primary analysis data cutoff date of September 6, 2022, to the date of unblinding on March 7, 2023.2

In addition to PFS, see more VORANIGO results from the extended analysis2,a:

TIME TO NEXT INTERVENTION

TUMOR GROWTH RATE

SEIZURE ACTIVITY

Explore the data

Watch Dr Tresa McGranahan and Dr Simon Khagi dive into the clinical data for VORANIGO

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The most common (≥15%) ARs on VORANIGO include fatigue, COVID-19, and musculoskeletal pain1

VORANIGO safety

VORANIGO directly inhibits mIDH1/2 enzymes to halt disease progression in glioma1,4

VORANIGO mechanism of action

AR, adverse reaction; HR, hazard ratio; mIDH, mutant isocitrate dehydrogenase; NE, not estimable.

References: 1. Voranigo. Package insert. Servier Pharmaceuticals LLC; 2025. 2. Mellinghoff IK, van den Bent MJ, Touat M, et al. A global, randomized, double-blinded, Phase 3 study of vorasidenib versus placebo in patients with adult-type diffuse glioma with an IDH1/2 mutation (INDIGO): UPDATED RESULTS. Presented at: Society for Neuro-Oncology Annual Meeting; November 21-24, 2024; Houston, TX. 3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Central Nervous System Cancers. V.2.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed September 12, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 4. Peters KB. Targeting mutant IDH to treat low-grade glioma. touchREVIEWS in Oncology & Haematology. 2023;19(2):7-11. https://doi.org/10.17925/OHR.2023.19.2.3

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IMPORTANT SAFETY INFORMATION

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.

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