Initial US Approval:
2024
Key Clinical Studies:
INDIGO trial (NCT04164901)
Drug Class/Description:
Isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor
Indications and Usage:
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.
Dosage Administration:
Recommended dosage in adults:
- 40 mg orally once daily.
Recommended dosage in pediatric patients 12 years of age and older based on body weight:
- ≥40 kg: 40 mg orally once daily.
- <40 kg: 20 mg orally once daily.
- Take with or without food.
Dosage Forms and Strengths:
Tablets: 10 mg and 40 mg.
Contraindications:
None.
Warnings and Precautions:
Hepatotoxicity: Monitor liver function tests every 2 weeks during the first 2 months of treatment, then monthly for the first 2 years of treatment, and as clinically indicated. Withhold, reduce the dose or discontinue VORANIGO based on severity.
Embryo-Fetal Toxicity: VORANIGO can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective nonhormonal contraception.
Adverse Reactions:
The most common (≥15%) adverse reactions include fatigue, headache, COVID-19, musculoskeletal pain, diarrhea, nausea, and seizure.
Grade 3 or 4 (≥2%) laboratory abnormalities were ALT increased, AST increased, GGT increased, and neutrophils decreased.
Use in Specific Populations:
Lactation: Advise not to breastfeed.
Infertility: May impair fertility in males and females.
Adapted from:
Every health-care provider should make their own determination regarding specific safe and appropriate patient care practices, including drug dosages and indications. The provider should always consult the most recent prescribing/product information. FDA Focus information is not guaranteed to be accurate, complete, or current. JADPRO and its editors, authors, reviewers, and commentators cannot be held responsible for any liability incurred as a consequence of the application of any of the information listed within.
