Servier receives approval from European Commission for Voranigo® (vorasidenib), first targeted therapy for Patients with Grade 2 IDH-mutant Glioma

§  Voranigo® has been granted marketing authorization by the European Commission (EC) as the first targeted therapy approved to treat Grade 2 IDH-mutant glioma in the EU.

§  Voranigo® demonstrated significant improvement in progression-free survival with a favorable safety profile in a pivotal Phase 3 study of patients with Grade 2 IDH-mutant glioma. 

Suresnes, France, September 22nd 2025 – Servier, an independent international pharmaceutical group governed by a foundation, today announces that the EC has approved Voranigo® (vorasidenib) for the treatment of predominantly non-enhancing Grade 2 astrocytoma or oligodendroglioma with an isocitrate dehydrogenase-1 (IDH1) R132 or isocitrate dehydrogenase-2 (IDH2) R172 mutation in adult and adolescent patients aged 12 years and older and weighing at least 40 kg who only had surgical intervention and who are not in immediate need of radiotherapy or chemotherapy. The decision to approve Voranigo® as the first targeted therapy to treat Grade 2 IDH-mutant glioma follows a positive opinion from the Committee for Medicinal Products (CHMP) for Human Use of the European Medicines Agency (EMA) on July 24th 2025.  

“Patients with Grade 2 IDH-mutant glioma have been waiting for over 20 years for innovative treatment, so we are thrilled to introduce the first targeted therapy in Europe for this rare and challenging brain cancer. With today’s approval of Voranigo, we initiate a new era for healthcare professionals reshaping the treatment landscape across the EU improving patient outcomes and tailored to their expressed needs. We are grateful to the researchers, physicians, patients and patient organizations who have helped expand our understanding of IDH inhibition, unveil glioma burden and bring this long-awaited breakthrough to the EU.”  Arnaud Lallouette, Executive Vice President, Global Medical & Patient Affairs, Servier. 

“People living with IDH-mutated gliomas are often in the prime of their lives — in their 30s and 40s — otherwise healthy, raising families, building careers, and looking ahead to the future. A diagnosis like this turns everything upside down. For the first time, there is real hope.” stated Bec Mallett, Founder and CEO of Peace of Mind Foundation1, Australia’s leading brain cancer support charity. 

The approval of Voranigo® is supported by results from the pivotal Phase 3 INDIGO clinical trial published in The New England Journal of Medicine and presented during the Plenary Session at the 2023 Annual Meeting of the American Society of Clinical Oncology (ASCO), which showed that Voranigo® significantly extended progression-free survival (PFS)  when compared to placebo. The INDIGO study showed that Voranigo ® has a manageable safety profile which was consistent with results from the Phase 1 studies.  

The marketing authorization covers the 27 countries of the European Union as well as Iceland, Liechtenstein, and Norway. 

Voranigo® has also been granted marketing authorization in the United States, Canada, Australia, Israel, the United Arab Emirates, Saudi Arabia, Switzerland, Brazil, the United Kingdom in Japan. Servier has submitted marketing authorization applications in various other regions as well and reviews by the respective health authorities are ongoing.