New Drug to be Marketed for Brain Cancers

Today, the FDA approved vorasidenib (Voranigo; Servier Pharmaceuticals) to treat patients ages 12 and older with grade 2 astrocytoma or oligodendroglioma with IDH1/2 mutations after they’ve had surgery. This is the first systemic therapy approved by the FDA for this condition. The decision was based on data INDIGO trial, in which 331 patients received either vorasidenib or a placebo; those in the placebo group could cross over to the vorasidenib arm if their disease advanced (N Engl J Med 2023;389:589–601). Progression-free survival was significantly longer in the vorasidenib group compared with the placebo group—27.7 months vs. 11.1 months, respectively. The median time until the next intervention was not reached in the vorasidenib arm and was 17.8 months in the placebo arm.