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Consider VORANIGO® for appropriate patients as a next step after surgery1

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NCCN Guidelines® Appropriate patients

National Comprehensive Cancer Network® (NCCN®) includes vorasidenib (VORANIGO) in guidance for treating Grade 2 mIDH glioma2

VORASIDENIB IS

NCCN

PREFERRED

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend vorasidenib (VORANIGO) for Grade 2 mIDH1/2 astrocytoma and oligodendroglioma for patients with a KPS ≥602,a

In the adjuvant setting

  • A preferred treatment option in patients without residual/measurable diseaseᵇ

  • An NCCN Category 1 preferred treatment option in patients with residual/measurable or recurrent disease, when up-front treatment with radiation therapy and chemotherapy is not preferred

In the recurrent/progressive setting after radiation therapy and chemotherapy

  • A preferred treatment optionc

VORANIGO is appropriate for Grade 2 mIDH glioma patients ≥12 years old after surgery, regardless of the extent of resection, time since surgery, and prior treatment history1

The patient criteria below illustrate types of appropriate patients for VORANIGO:

VORANIGO patient criteria chart
  • Based on the approved indication and your clinical assessment, VORANIGO can be used:
    • Immediately after surgery
    • After sub-total resection or gross total resection
    • After surgery alone or after surgery and prior therapy

aIf an IDH inhibitor is being considered for a patient with newly diagnosed oligodendroglioma or astrocytoma, the NCCN Panel strongly recommends multidisciplinary discussion or referral to a brain tumor center for consultation.1

bNewly diagnosed patients with oligodendroglioma/astrocytoma who did not have residual disease were excluded from participation in the INDIGO study. Therefore, it is unknown if this subset of patients would benefit from immediate treatment with an IDH inhibitor. The safety of long-term treatment with IDH inhibitors is unknown. NCCN recommends discussing the possible risks and benefits of starting treatment right away with an IDH inhibitor with these patients.1

cFor recurrent disease, there are multiple reasonable options, but there is no uniformly recommended option at this time.1

See examples of patients who are appropriate for treatment with VORANIGO

KPS, Karnofsky Performance Status; mIDH, mutant isocitrate dehydrogenase.

References: 1. Voranigo. Package insert. Servier Pharmaceuticals LLC; 2025. 2. 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.

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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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