Vorasidenib

Vorasidenib (Voranigo) received FDA approval for IDH1/2-mutant glioma treatment, marking the first systemic medication for low-grade glioma in over 20 years. The INDIGO trial showed a median progression-free survival of 27.7 months with vorasidenib vs 11.1 months with placebo. Vorasidenib is well-tolerated, with common side effects being fatigue, headache, and nausea, mostly grade 1. The approval allows for broader use, but careful patient-provider discussions are essential due to potential overtreatment risks and patient-specific considerations.

Vorasidenib, a dual inhibitor of IDH1 and IDH2 mutations, offers a breakthrough in treating IDH-mutated, grade two glioma, significantly improving progression-free survival and crossing the blood-brain barrier effectively.

Dr. Darrell Bigner's team discovered a point mutation in the isocitrate dehydrogenase gene in brain tumors, leading to the development of vorasidenib (Voranigo) by Servier Pharmaceuticals. The drug, approved by the FDA, treats one-third of primary brain tumor types and has shown promising results in clinical trials at Duke, with patients experiencing stable MRIs and no tumor progression.

FDA approves Voranigo (vorasidenib), an IDH1 and IDH2 inhibitor, for treating Grade 2 IDH-mutant glioma in patients 12+ years old post-surgery. Voranigo offers a once-daily pill for disease management, with Phase 3 INDIGO trial results showing significant progression-free survival extension and safety.