The European Commission (EC) has sanctioned the use of Servier’s Voranigo (vorasidenib) to treat certain brain tumours, specifically non-enhancing grade 2 astrocytoma or oligodendroglioma with identified mutations in the isocitrate dehydrogenase-1 (IDH1) R132 or isocitrate dehydrogenase-2 (IDH2) R172.
The approval is designated for adults and adolescents aged 12 years and above, with a minimum body weight of 40kg, who have undergone surgical treatment and do not currently require chemotherapy or radiotherapy.
Voranigo’s approval as an inaugural targeted therapy to treat grade 2 IDH-mutant glioma follows a favourable opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in July 2025.
The EC's endorsement is now effective in all 27 European Union (EU) member states, Iceland, Liechtenstein and Norway.
The approval is based on findings from the Phase III INDIGO study, which indicated that the therapy improved progression-free survival (PFS) and the time to next intervention (TTNI) against a placebo.
The trial also reported that the therapy was well-tolerated and that its safety profile was in line with the outcomes from initial Phase I trials.
Servier LS/LCM senior director and development-neuro-oncology global head Islam Hassan stated: "Today's EU approval of Voranigo is a landmark moment for people in the EU living with IDH-mutated glioma who have been waiting more than two decades for new treatment options.
Voranigo is the first EMA-approved therapy specifically designed to target mutant IDH enzymes in Grade 2 glioma and represents a long-awaited shift in the treatment paradigm.”
Voranigo has been authorised for marketing in Australia, Brazil, Canada, Israel, Japan, Saudi Arabia, Switzerland, the United Arab Emirates, the UK, Japan the US.
The company has applied for marketing authorisations for the therapy in other regions, with reviews by local health authorities in progress.
In a recent strategic move, Servier agreed to acquire Kaerus Bioscience’s potential Fragile X syndrome (FXS) treatment, KER-0193.
