Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that IDH1 p.R132L status confers therapeutic sensitivity to Vorasidenib in patients with Oligodendroglioma.

The European Medicines Agency (EMA) has authorized vorasidenib as a monotherapy for the treatment of adult and adolescent patients aged 12 years and older with predominantly non-enhancing Grade 2 astrocytoma or oligodendroglioma with an IDH1 R132 or IDH2 R172 mutation. Eligible patients must be weighing at least 40 kg and who only had surgical intervention and are not in immediate need of radiotherapy or chemotherapy.

This statement is based on a regulatory approval from the European Medicines Agency:

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.

Citation

Les Laboratoires Servier. Voranigo (vorasidenib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/voranigo-epar-product-information_en.pdf. Revised September 2025. Accessed October 2, 2025.

Contributions

Date	Contributor	Description
2025-10-02	Van Allen lab	On 2025-09-26 the EMA granted initial market authorization to Voranigo (vorasidenib) for the treatment of patients with astrocytoma or oligodendroglioma with an IDH1 R132 or IDH2 R172 mutation.
2025-09-17	European Medicines Agency	Indication received approval from the European Commission.