Is Voranigo (Vorasidenib) on the market?

Voranigo (Vorasidenib) is an anti-cancer drug used to treat certain forms of glioma. It is sold under the trade name Voranigo and is developed by Servier Pharmaceuticals. Vorasidenib inhibits isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2). Vorasidenib was approved for medical use in the United States in August 2024, marking the first time the U.S. Food and Drug Administration (FDA) has approved systemic treatment for patients with grade 2 astrocytoma or oligodendroglioma susceptible to IDH1 or IDH2 mutations.

Glioma is a type of brain cancer that blocks normal brain function and causes a variety of symptoms. Diffuse gliomas with IDH mutations are the most common malignant primary brain tumors diagnosed in adults younger than 50 years of age. Current treatments cannot cure them, and if left untreated, they continue to grow and infiltrate normal brain tissue.

The U.S. Food and Drug Administration's approvalVoranigo is based on results from the pivotal Phase 3 INDIGO clinical trial, in which vo Patients in the rasidenib group showed prolonged progression-free survival (median 27.7 months, compared with 11.1 months in the placebo group) and reduction in tumor volume (an average of 2.5% every 6 months, compared with an average increase of 13.9% every 6 months in the placebo group).

Voranigo binds to two proteins in brain tumor cells. This blocks the activity of these proteins, thereby reducing brain tumor growth. Voranigo is available in oral tablet forms of 10 mg and 40 mg, and the dosage is adjusted according to the condition. The most common adverse reactions of Voranigo are fatigue, headache, COVID-19 infection, musculoskeletal pain, diarrhea, nausea and seizures.