Overview

• The authorization covers patients aged 12 years and older who weigh at least 40 kg with predominantly non‑enhancing grade 2 astrocytoma or oligodendroglioma harboring IDH1 R132 or IDH2 R172 mutations after surgery when radiotherapy or chemotherapy is not immediately required.
• INDIGO showed median progression-free survival of 27.7 months with vorasidenib versus 11.1 months with placebo, corresponding to a hazard ratio of 0.39 (P < .001).
• Time to next intervention was markedly delayed, with the median not reached on vorasidenib versus 17.8 months on placebo, and 18‑month freedom from next treatment of 85.6% versus 47.4%.
• Safety was consistent with earlier studies, with any‑grade adverse events in 94.6% of patients, commonly ALT elevation (38.9%) and fatigue (32.3%), and grade 3 or higher events in 22.8% requiring monitoring and dose management in some cases.
• The decision follows a July 2025 positive CHMP opinion and takes effect across all EU member states plus Iceland, Liechtenstein, and Norway, while Servier notes existing authorizations in several non‑EU countries and ongoing reviews elsewhere.