Vorasidenib

(Voranigo®)

Voranigo®

Drug updated on 9/4/2024

Dosage FormTablet (oral; 10 mg, 40 mg)
Drug ClassIsocitrate dehydrogenase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection, or gross total resection.

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Summary
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  • Voranigo (Vorasidenib) is indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery, including biopsy, subtotal resection, or gross total resection.
  • This summary is based on the review of one randomized controlled trial(s). [1]
  • Vorasidenib, an IDH inhibitor, has demonstrated significant efficacy in treating grade 2 gliomas in patients who have not previously undergone radiotherapy (RT) or chemotherapy (CT), suggesting it may be an effective treatment option for this population.
  • No direct comparative effectiveness data is provided between vorasidenib and other treatment modalities such as surgery, RT, or CT within the same study.
  • The studies do not detail differences in effectiveness among various population types or subgroups, limiting conclusions on subgroup-specific efficacy.
  • There is no safety information available in the reviewed studies.
  • The studies focus on adult patients with grade 2 gliomas, particularly oligodendrogliomas and astrocytomas with IDH mutations, and highlight the significant efficacy of IDH inhibitors like vorasidenib in these tumors not previously treated with RT or CT; no additional subgroup-specific findings are available.

Product Monograph / Prescribing Information

Document TitleYearSource
VORANIGO (vorasidenib) Prescribing Information2024Servier Pharmaceuticals LLC, Boston, MA

Randomized Controlled Trials

Document TitleSex DistributionYearSource
Vorasidenib in IDH1- or IDH2-mutant low-grade glioma.
168Subjects
F: 60%
M: 40%
2023The New England Journal of Medicine

Sex Distribution:

F:60%
M:40%
168Subjects

Year:

2023

Source:The New England Journal of Medicine

Clinical Practice Guidelines

Document TitleYearSource
NCCN Clinical Practice Guidelines in Oncology. Central Nervous System Cancers, Version 2.2024.2024National Comprehensive Cancer Network
SEOM-GEINO clinical guidelines for grade 2 gliomas (2023). 2024Clinical and Translational Oncology