FDA approved Voranigo (vorasidenib) for IDH-Mutant Grade 2 GliomaFDA approved new targeted drug Voranigo for certain brain tumors.

FDA From the archive Source published August 6, 2024 Summary added June 13, 2026 DOI ↗ Editorial oversight: Dr. Julia Lee, PhD · Oncology, Genomics & Drug Development

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Key Takeaway

Consider Voranigo for patients 12+ with IDH-mutant Grade 2 glioma after surgery; monitor liver function closely.

The FDA has approved Voranigo (vorasidenib), an IDH1/IDH2 inhibitor, for the treatment of adult and pediatric patients aged 12 years and older with Grade 2 astrocytoma or oligodendroglioma that harbor a susceptible IDH1 or IDH2 mutation, as detected by an FDA-approved test. The indication is for patients following surgery, including biopsy, sub-total resection, or gross total resection. This approval provides a targeted therapy option for this patient population, which previously had limited systemic treatment choices. The efficacy was evaluated in the INDIGO trial, a randomized, double-blind, placebo-controlled study of 331 patients. Clinicians should note that patient selection requires confirmation of IDH1 or IDH2 mutations via an FDA-approved test.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Voranigo is an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor.

Indication & Patient Population

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, as detected by an FDA-approved test, following surgery including biopsy, sub-total resection, or gross total resection.

Dosing & Administration

Recommended dosage in adults: 40 mg orally once daily. In pediatric patients 12 years and older: based on body weight: ≥40 kg: 40 mg once daily; <40 kg: 20 mg once daily. Take with or without food. Swallow tablets whole; do not split, crush, or chew. Continue until disease progression or unacceptable toxicity. Dosage reductions for adverse reactions are provided in the label.

Key Clinical Trial Data

The efficacy of VORANIGO was evaluated in the INDIGO trial (Study AG881-C-004), a randomized, multicenter, double-blind, placebo-controlled study of 331 patients (NCT04164901). Eligible patients had IDH1- or IDH2-mutant Grade 2 astrocytoma or oligodendroglioma with prior surgery.

Warnings & Contraindications

Before initiating VORANIGO, evaluate blood chemistry and liver laboratory tests. Hepatotoxicity (elevation of ALT or AST) requires monitoring and dose modifications as per label. Permanently discontinue for Grade 4 hepatotoxicity or recurrent Grade 3 other adverse reactions.

Place in Therapy

Voranigo is a targeted therapy for patients with IDH-mutant Grade 2 gliomas after surgery. It offers a systemic treatment option for this specific molecular subtype.

The FDA has approved a new drug called Voranigo (vorasidenib) for certain types of slow growing brain tumors. It is for adults and children aged 12 and older who have Grade 2 astrocytoma or oligodendroglioma. These tumors must have a specific change in the IDH1 or IDH2 gene. Doctors will use an FDA approved test to check for this mutation. The drug is taken after surgery, whether the surgery removed all, part, or just a sample of the tumor.

This approval is based on a study called INDIGO. In the study, patients who took Voranigo had better outcomes than those who took a placebo. This is the first targeted therapy approved for this group of patients. Before this, there were few medicine options available.

Voranigo works by blocking the activity of the mutated IDH proteins. This can help slow or stop the growth of the tumor. It is a pill taken by mouth.

If you or a loved one has one of these brain tumors, talk to your doctor. They can help you understand if Voranigo might be an option. This drug is not for everyone. It is only for people with the specific IDH mutation. Your doctor can order the test to find out.

What this means for you:

Voranigo is a new targeted pill for certain brain tumors with an IDH mutation, offering a new option after surgery.

Study Details

Study typeFda approval

PublishedAug 2024

View Original Abstract ↓

1 INDICATIONS AND USAGE VORANIGO 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, as detected by an FDA-approved test, following surgery including biopsy, sub-total resection, or gross total resection [see Dosage and Administration (2.1) , Clinical Pharmacology (12.1) and Clinical Studies (14) ] . VORANIGO is an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor 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, as detected by an FDA-approved test, following surgery including biopsy, sub-total resection, or gross total resection. ( 1 )

FDA approved Voranigo (vorasidenib) for IDH-Mutant Grade 2 GliomaFDA approved new targeted drug Voranigo for certain brain tumors.

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FDA approved Voranigo (vorasidenib) for IDH-Mutant Grade 2 GliomaFDA approved new targeted drug Voranigo for certain brain tumors.

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