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VORANIGO® is the only targeted therapy approved for Grade 2 mIDH glioma 

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Molecular profiling in glioma classification Unmet need in mIDH glioma VORANIGO expands treatment options

Molecular profiling in glioma classification

Identifying mutations is the key to precisely classifying adult-type diffuse gliomas

  • The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend conducting initial IDH testing for the workup of all gliomas, followed by additional molecular characterization1,2
  • Adult-type diffuse gliomas, a subtype of glioma, are further categorized into 3 subtypes according to the mutational status of IDH and 1p/19q-codeletion in the 2021 WHO classification2

2021 WHO classification of adult-type diffuse gliomas2

Adult-type diffuse glioma Genes and altered molecular profiles CNS WHO Grade
Astrocytoma mutated IDH1 and IDH2 2, 3, 4
Oligodendroglioma mutated IDH1 and IDH2, and 1p/19q-codeleted 2, 3
Glioblastoma wild-type IDH 4

amIDH glioma cells include astrocytes and oligodendrocytes that are mutated in adult-type diffuse glioma.

Gliomas with mutated IDH1 and IDH2 have improved prognoses compared to gliomas with wild-type IDH (glioblastoma)3-5

Identifying your patients' IDH mutation may require NGS if IHC is negative1,6

  • While IHC can identify the most common IDH1 mutation, R132H, up to 16% of patients with mIDH glioma have an IDH1 or IDH2 mutation that requires NGS to be detected7,8
    • VORANIGO has an FDA-approved NGS companion diagnostic that tests for IDH1 and IDH2 mutations6,9
NCCN guidelines.

According to the NCCN Guidelines®, if the IHC result for mIDH1-R132H is negative for a patient under age 55, sequencing is required to detect less common IDH1 and IDH2 mutations1

Even following gross total resection (GTR), mIDH gliomas continue to grow

IDH1/2-mutant astrocytomas and oligodendrogliomas grow continuously over time regardless of the extent of resection10,11

The presence of residual tumor cells remains after surgery due to the diffuse and infiltrative nature of mIDH gliomas11,12

mIDH gliomas eventually become aggressive and may lead to premature death10,12

See tumor growth rate data in patients with mIDH glioma treated with VORANIGO vs active observation

Explore the data

VORANIGO is the first FDA-approved treatment for mIDH glioma in >20 years6,13,14

Prior to the approval of VORANIGO, an FDA-approved targeted treatment option specifically designed for mIDH glioma did not exist, and treatment options were limited to active observation or radiotherapy and/or chemotherapy (RT/CT)

VORANIGO may be considered as a targeted option in multiple treatment settings, including immediately following surgery1,6,15

MRI findings suggest glioma. Tumor resection (STR, GTR) or biopsy and Grade 2 mIDH glioma diagnosis confirmation.

Up-front treatment optionsb

Up-front treatment options are active observation, VORANIGO, RT/CT.

Recurrence optionsb

Recurrence options are re-section, VORANIGO, RT/CT.

bAdditional treatment options, including clinical trial enrollment or palliative care, may be considered.

VORASIDENIB IS

NCCN

PREFERRED

National Comprehensive Cancer Network® (NCCN®) includes vorasidenib (VORANIGO) in guidance for treating Grade 2 mIDH glioma1

Learn more
See how VORANIGO works in mIDH glioma

CNS, central nervous system; IDH, isocitrate dehydrogenase; IHC, immunohistochemistry; mIDH, mutant isocitrate dehydrogenase; MRI, magnetic resonance imaging; NGS, next-generation sequencing; STR, sub-total resection; WHO, World Health Organization.

References: 1. 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. 2. Louis DN, Perry A, Wesseling P, et al. The 2021 WHO Classification of Tumors of the Central Nervous System: a summary. Neuro Oncol. 2021;23(8):1231-1251. doi:10.1093/neuonc/noab106 3. Stupp R, Mason WP, van den Bent MJ, et al. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005;352(10):987-996. doi:10.1056/NEJMoa043330 4. Pekmezci M, Rice T, Molinaro AM, et al. Adult infiltrating gliomas with WHO 2016 integrated diagnosis: additional prognostic roles of ATRX and TERT. Acta Neuropathol. 2017;133(6):1001-1016. doi:10.1007/s00401-017-1690-1 5. Bell EH, Zhang P, Shaw EG, et al. Comprehensive genomic analysis in NRG oncology/RTOG 9802: a phase III trial of radiation versus radiation plus procarbazine, lomustine (CCNU), and vincristine in high-risk low-grade glioma. J Clin Oncol. 2020;38(29):3407-3417. doi:10.1200/JCO.19.02983 6. Voranigo. Package insert. Servier Pharmaceuticals LLC; 2025. 7. Yan H, Parsons DW, Jin G, et al. IDH1 and IDH2 mutations in gliomas. N Engl J Med. 2009;360(8):765-773. doi:10.1056/NEJMoa0808710 8. Tesileanu CMS, Vallentgoed WR, Sanson M, et al. Non-IDH1-R132H IDH1/2 mutations are associated with increased DNA methylation and improved survival in astrocytomas, compared to IDH1-R132H mutations. Acta Neuropathol. 2021;141(6):945- 957. doi:10.1007/s00401-021-02291-6 9. List of cleared or approved companion diagnostic devices (in vitro and imaging tools). US Food and Drug Administration. Updated March 5, 2025. Accessed August 27, 2025. https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools 10. 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 11. 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 12. Smits A, Jakola AS. Clinical presentation, natural history, and prognosis of diffuse low-grade gliomas. Neurosurg Clin N Am. 2019;30(1):35-42. doi:10.1016/j.nec.2018.08.002 13. Ninatti G, Moresco RM, Sollini M. Molecular imaging of IDH-mutant gliomas in the new era of IDH inhibitors: preparing for future challenges. Eur J Nucl Med Mol Imaging. 2024;51(5):1421-1422. doi:10.1007/s00259-024-06591-3 14. 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 15. Darlix A, Preusser M, Hervey-Jumper SL, Shih HA, Mandonnet E, Taylor JW. Who will benefit from vorasidenib? Review of data from the literature and open questions. Neuro-Oncology Practice. 2024. doi.org/10.1093/nop/npae104

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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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