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Molecular profiling in glioma classification

Identifying mutations is the key to precisely classifying adult-type diffuse glioma1,2

  • The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend conducting initial IDH testing for the workup of all gliomas, followed by additional molecular characterization
  • 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 classification

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

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

Test all patients with IHC and NGS to identify all mutations1

  • 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 detected6,7

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

See how VORANIGO works in mIDH glioma

IHC, immunohistochemistry; mIDH1/2, mutant isocitrate dehydrogenase-1 or mutant isocitrate dehydrogenase-2; NCCN, National Comprehensive Cancer Network® (NCCN®); NGS, next-generation sequencing; 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.4.2024. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed January 22, 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. 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 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

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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 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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