VORANIGO

What it is

Voranigo is a small molecule dual inhibitor that targets the mutant IDH1 and IDH2 enzymes. It is available in 10 mg and 40 mg film-coated tablets. This medicinal product is subject to additional monitoring in Australia.

Approved indications

— Treatment of 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.

Dosing overview

The recommended dose of Voranigo in adults and adolescents 12 years of age and older is 40 mg taken orally once daily for patients weighing at least 40 kg, or 20 mg taken orally once daily for patients weighing less than 40 kg. Treatment should be continued until disease progression or unacceptable toxicity. The tablets should be taken once daily at about the same time each day, and patients should not eat food at least 2 hours before and 1 hour after taking Voranigo.

Key safety warnings

Voranigo can cause hepatic transaminase elevations, which can lead to hepatic failure, hepatic necrosis and autoimmune hepatitis. In the INDIGO clinical trial, 18.6% of patients treated with Voranigo experienced elevations in alanine aminotransferase (ALT) greater than 3 times the upper limit of normal (ULN) and 8.4% experienced elevations in aspartate aminotransferase (AST) greater than 3 times the ULN. Among these patients, 1.2% had concurrent elevations in ALT or AST greater than 3 times the ULN and total bilirubin greater than 2 times the ULN. Liver laboratory tests (ALT, AST, gamma-glutamyl transferase and alkaline phosphatase) and total bilirubin must be monitored prior to the start of Voranigo, every 2 weeks during the first 2 months of treatment, then once monthly for the first 2 years of treatment and as clinically indicated thereafter, with more frequent testing in patients who develop transaminase elevations. Voranigo could cause fetal harm when administered to a pregnant woman. Pregnancy testing is recommended in women of childbearing potential prior to starting treatment. Women of childbearing potential should use effective non-hormonal contraception during treatment and for at least 3 months after the last dose of Voranigo. Voranigo may decrease concentrations of hormonal contraceptives and, therefore, concomitant use of a barrier method of contraception is recommended during the treatment and for at least 3 months after the last dose.

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Voranigo should not be used in patients with pre-existing severe hepatic impairment.

PBS listing

No source document contains information about PBS listing status, item count, restriction type, or ex-manufacturer price for Voranigo.

Regulatory history

Voranigo vorasidenib 10 mg and 40 mg tablets were first listed on the Australian Register of Therapeutic Goods on 11 September 2024. In July 2025, the PBAC recommended not proceeding with Voranigo for isocitrate dehydrogenase-mutant astrocytoma or oligodendroglioma, noting that benefits claimed were overly optimistic and that a risk sharing arrangement would be required.