European Commission Approves Servier’s VORANIGO for Treatment of Grade 2 IDH-Mutant Glioma

Servier, the independent international pharmaceutical group, announced that the European Commission (EC) has approved VORANIGO (vorasidenib) for treating predominantly non-enhancing Grade 2 astrocytoma or oligodendroglioma with specific IDH1 or IDH2 mutations in adults and adolescents aged 12 years and older who weigh at least 40 kg. This approval applies to patients who have only undergone surgery and are not in immediate need of radiotherapy or chemotherapy. The decision follows a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in July 2025.

Gliomas are a form of brain cancer that impair normal brain function and cause various symptoms, with IDH-mutated diffuse gliomas being the most common malignant brain tumors in adults under 50. Historically, treatment options have been limited, and untreated tumors tend to grow and infiltrate healthy brain tissue.

Islam Hassan, Servier’s Global Head of Development-Neuro-Oncology, described the approval as a landmark achievement for patients in the EU who have waited more than 20 years for new treatment options. He highlighted VORANIGO as the first therapy approved by the EMA specifically designed to target mutant IDH enzymes in Grade 2 glioma, marking a significant shift in the treatment landscape.

The EC’s decision applies across the 27 EU member states as well as Norway, Liechtenstein, and Iceland.

VORANIGO’s approval was supported by results from the Phase 3 INDIGO clinical trial, published in The New England Journal of Medicine and presented at the 2023 ASCO Annual Meeting. The trial demonstrated that VORANIGO significantly extended progression-free survival and delayed the need for further intervention compared to placebo. The drug was well tolerated, with common side effects including fatigue, COVID-19, musculoskeletal pain, diarrhea, and seizures.

In addition to the EU, VORANIGO has been authorized in the United States, Canada, Australia, Israel, the UAE, Saudi Arabia, Switzerland, Brazil, the United Kingdom, and Japan. Servier has submitted applications in other regions and is awaiting regulatory reviews.