Voranigo Approved for Glioma
On Aug. 6, 2024, the U.S. Food and Drug Administration (FDA) approved Servier Pharmaceuticals’ Voranigo® (vorasidenib) for the treatment of adult and pediatric patients 12 years of age and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutations following surgery. As an oral IDH1 and IDH2 inhibitor, it’s the first targeted therapy for patients with Grade 2 IDH-mutant glioma. The recommended dose in adults is 40mg once daily. Dosing in children 12 and older is based on body weight. Children weighing at least 40kg (approximately 88 pounds) should receive the adult dose of 40mg once daily. Dosing in children weighing less than 40kg is 20mg once daily. According to Servier, Voranigo will be launched immediately. Pricing information is not yet available. Full prescribing information can be found here.
At a Glance
- Brand Drug: Voranigo® (vorasidenib)
- Manufacturer: Servier Pharmaceuticals
- Date Approved: Aug. 6, 2024
- Indication: 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
- Dosage Forms Available: 10mg and 40mg tablets
- Launch Date: Upon approval
- Estimated Annual Cost: Not yet available
- Astrocytoma and oligodendroglioma are types of brain cancer. Grade 2 forms of these gliomas tend to spread into surrounding brain tissue. Approximately 1,500 new cases of these two types of IDH-mutant gliomas are diagnosed each year in the United States. Diffuse gliomas with IDH mutations are a common brain cancer type in patients younger than 50 years of age.
- Approval was based on a Phase III study that found that median progression-free survival (PFS) was 27.7 months for patients treated with Voranigo compared to 11.1 months for patients treated with placebo. This result was deemed statistically significant and clinically meaningful.
- The most common adverse events experienced by patients in the trial were fatigue, COVID-19, musculoskeletal pain, diarrhea, and seizures.
- Voranigo received a priority review and was granted fast-track, breakthrough therapy, and orphan drug designations. Additionally, it was reviewed using Assessment Aid and Project Orbis, which are FDA procedures that speed up approvals for drugs that may fill critical unmet needs.