Voranigo (vorasidenib), made by French drugmaker Servier Pharmaceuticals, was approved in August by the US Food and Drug Administration. The small-molecule isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor has the go-ahead to treat patients with grade 2 astrocytoma or oligodendroglioma with IDH1 or IDH2 mutations.
The approval follows a successful phase 3 trial showing that Voranigo more than doubled the mean progression-free survival in patients with residual or recurrent grade 2 IDH-mutant glioma after surgery. Patients treated with vorasidenib had a median progression-free survival of 27.7 months, compared with 11.1 months for those receiving a placebo.