Voranigo FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 7, 2024.
FDA Approved: Yes (First approved August 6, 2024)
Brand name: Voranigo
Generic name: vorasidenib
Dosage form: Tablets
Company: Servier Pharmaceuticals
Treatment for: Malignant Glioma
Voranigo (vorasidenib) is an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor for the treatment of Grade 2 IDH-mutant glioma.
- Voranigo 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, sub-total resection, or gross total resection.
- Gliomas are brain tumors that arise from glial or precursor cells within the central nervous system. There are four groups of gliomas, with adult-type diffuse gliomas representing approximately 81 percent of primary malignant brain tumors. Of those, approximately 20 percent harbor an IDH mutation. Adult-type diffuse gliomas are subcategorized as astrocytoma, IDH-mutant (CNS WHO grades 2-4), oligodendroglioma, IDH-mutant and1p19q-codeleted (CNS WHO grades 2-3), and glioblastoma, IDH-wildtype (CNS WHO grade 4).
- Voranigo contains vorasidenib, a brain-penetrant, dual inhibitor of mutant IDH1 and IDH2 enzymes. IDH enzymes help break down nutrients and generate energy for cells, and mutations in IDH1 and IDH2 are associated with a variety of cancers. Voranigo works by reducing the activity of the mutant IDH1 and IDH2 enzymes to decrease the production of 2-hydroxyglutarate (2-HG) involved in tumor survival and progression.
- FDA approval of Voranigo was based on results from the pivotal Phase 3 INDIGO clinical trial in which patients in the vorasidenib group demonstrated significantly extended progression free survival (median 27.7 months compared to 11.1 months for patients in the placebo group) and a reduction in tumor volume (mean of 2.5% every 6 months compared to a mean increase of 13.9% every 6 months for patients in the placebo group).
- Voranigo tablets are administered orally once daily.
- Warnings and precautions associated with Voranigo include hepatotoxicity and fetal harm.
- Common (≥15%) adverse reactions include fatigue, headache, COVID-19, musculoskeletal pain, diarrhea, nausea, and seizure.
Grade 3 or 4 (≥2%) laboratory abnormalities include increased ALT, increased AST, increased GGT, and decreased neutrophils.
Development timeline for Voranigo
Further information
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