Regulatory approval
Published by the European Medicines Agency. Approved
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.
This is written in the approval document.
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
Organizations
Biomarkers
Cancer types
Therapies
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. |