Voranigo
Authorised
This medicine is authorised for use in the European Union
vorasidenib
Medicine
Human
Authorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Voranigo is a cancer medicine used to treat cancers of the brain called astrocytoma or oligodendroglioma in adults and adolescents from 12 years of age who weigh at least 40 kg, have had surgery as their only treatment and do not need other treatments such as radiotherapy or chemotherapy immediately.
It is used for tumours that are mainly slow growing (grade 2) and when the cancer cells have specific changes in the genes (mutations) that make proteins known as isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2).
Voranigo contains the active substance vorasidenib.
The medicine can only be obtained with a prescription. Treatment should be started and supervised by a doctor experienced in the use of cancer medicines.
Before treatment starts, the doctor will carry out tests to check whether the cancer cells have mutations in genes for IDH1 and IDH2.
Voranigo is available as tablets which the patient should take once a day by mouth at about the same time each day. The patient should not eat at least 2 hours before and 1 hour after taking Voranigo. Treatment lasts for as long as the patient benefits from it and does not have intolerable side effects.
For more information about using Voranigo, see the package leaflet or contact your doctor or pharmacist.
In patients with astrocytoma or oligodendroglioma who have mutations in the genes for the IDH1 and IDH2 protein, these proteins do not work properly, causing the production of high levels of a substance called 2-hydroxyglutarate (2-HG).
2-HG causes changes in the way cells grow and mature, leading to the development of tumours. The active substance in Voranigo, vorasidenib, blocks the activity of the abnormal IDH1 and IDH2 proteins, thereby reducing levels of 2-HG. This allows the cells to grow and mature normally, preventing the tumour from growing.
A main study involved 331 patients with grade 2 oligodendroglioma or astrocytoma with an IDH1 or IDH2 mutation and who had undergone surgery at least once to remove the tumour. The results showed that Voranigo was effective at preventing the disease from getting worse. In this study patients who had Voranigo lived for around 28 months without the disease getting worse, while those who had a placebo (a dummy treatment) lived for around 11 months without their disease worsening.
For the full list of side effects and restrictions with Voranigo, see the package leaflet.
The most common side effects with Voranigo (which may affect more than 1 in 10 people) include raised levels of liver enzymes, tiredness and diarrhoea.
Some side effects can be serious. The most frequent (which may affect up to 1 in 10 people) include raised levels of liver enzymes.
Voranigo is effective at slowing the worsening of low-grade astrocytoma or oligodendroglioma. The medicine can therefore help patients avoid aggressive treatments, such as chemotherapy or radiotherapy. The main side effects are related to liver problems, but most side effects in the main study were not considered serious. The known side effects are considered manageable and more information about the safety of the medicine will come from future studies.
The European Medicines Agency therefore decided that Voranigo’s benefits are greater than its risks and that it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Voranigo have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Voranigo are continuously monitored. Suspected side effects reported with Voranigo are carefully evaluated and any necessary action taken to protect patients.
Voranigo received a marketing authorisation valid throughout the EU on 17 September 2025.
Product information
17/09/2025
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Voranigo
- Active substance
- vorasidenib
- International non-proprietary name (INN) or common name
- vorasidenib
- Therapeutic area (MeSH)
- Oligodendroglioma
- Astrocytoma
- Anatomical therapeutic chemical (ATC) code
- L01XM04
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Voranigo as monotherapy is indicated for the treatment of predominantly non‑enhancing Grade 2 astrocytoma or oligodendroglioma with an IDH1 R132 or 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 are not in immediate need of radiotherapy or chemotherapy (see section 5.1).
News on Voranigo
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