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Voranigo (vorasidenib)
Australian Prescription Medicine Decision Summary
Published
Product name
Voranigo
Active ingredient
vorasidenib
Submission type
Type A - New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Voranigo was approved to treat Grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation or isocitrate dehydrogenase-2 (IDH2) mutation in adults and paediatric patients 12 years and older, who are not in need of immediate chemotherapy or radiotherapy following surgical intervention.
How this medicine works
Vorasidenib is a brain-penetrant, small molecule, dual inhibitor that targets the mutant isocitrate dehydrogenase 1 (IDH1) and IDH2 enzymes. In patients with astrocytoma or oligodendroglioma, IDH1 and IDH2 mutations lead to overproduction of the oncogenic metabolite 2-hydroxyglutarate (2-HG), resulting in impaired cellular differentiation and increased cellular proliferation contributing to oncogenesis. Direct inhibition of the gain-of-function activity of the IDH1- and IDH2-mutated proteins by vorasidenib is intended to inhibit the abnormal production of 2-HG and impact clinical outcomes through the differentiation of malignant cells and reduction of cellular proliferation.
Why the TGA approved or did not approve this medicine
The decision was based on:
- Quality (chemistry and manufacturing),
- Nonclinical (pharmacology and toxicology),
- Clinical (pharmacology, safety and efficacy) and
- Risk management plan information submitted by the sponsor.
The Sponsor demonstrated the efficacy of Voranigo in patients in a pivotal clinical study (Study AG881-C-004), "INDIGO", a phase 3, multi-centre, randomised, double-blind, placebo-controlled study of vorasidenib in subjects with residual or recurrent Grade 2 glioma with an isocitrate dehydrogenase (IDH)1 or IDH2 mutation. Vorasidenib is an inhibitor of the isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) proteins that carry certain mutations. As a result, a substance called 2-hydroxyglutarate (2-HG) is overproduced which contributes to the formation of cancer cells.
The primary study objective was to demonstrate the efficacy of vorasidenib based on radiographic progression-free survival compared with placebo in subjects with residual or recurrent Grade 2 oligodendroglioma and astrocytoma with an IDH1 or IDH2 mutation who have undergone surgery as their only treatment.
Consumer Medicine Information (CMI)
The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more.
The Australian CMIs can be accessed through the ARTG details hyperlinks below.
Product Information (PI)
The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.
The Australian PIs can be accessed through the ARTG details hyperlinks below.
Other resources
For health advice and information, including a symptom checker and service finder refer to the healthdirect website.
For advice on prescription medicines, over the counter medicines and other medicines (including complementary medicines) call Medicines Line.
For information on medicines subsidised by the Australian Government refer to the Pharmaceutical Benefits Scheme (PBS) website.
For data and reports on health and welfare topics in Australia refer to the Australian Institute of Health and Welfare website.