Voranigo (vorasidenib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

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.

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Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication Statements
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. 20

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organization(s) Biomarker(s) Cancer type Therapy(ies)
EMA (1) IDH1 p.R132C Astrocytoma Vorasidenib
EMA (1) IDH1 p.R132G Astrocytoma Vorasidenib
EMA (1) IDH1 p.R132H Astrocytoma Vorasidenib
EMA (1) IDH1 p.R132L Astrocytoma Vorasidenib
EMA (1) IDH1 p.R132S Astrocytoma Vorasidenib
EMA (1) IDH2 p.R172K Astrocytoma Vorasidenib
EMA (1) IDH2 p.R172M Astrocytoma Vorasidenib
EMA (1) IDH2 p.R172G Astrocytoma Vorasidenib
EMA (1) IDH2 p.R172S Astrocytoma Vorasidenib
EMA (1) IDH2 p.R172W Astrocytoma Vorasidenib
EMA (1) IDH1 p.R132C Oligodendroglioma Vorasidenib
EMA (1) IDH1 p.R132G Oligodendroglioma Vorasidenib
EMA (1) IDH1 p.R132H Oligodendroglioma Vorasidenib
EMA (1) IDH1 p.R132L Oligodendroglioma Vorasidenib
EMA (1) IDH1 p.R132S Oligodendroglioma Vorasidenib
EMA (1) IDH2 p.R172K Oligodendroglioma Vorasidenib
EMA (1) IDH2 p.R172M Oligodendroglioma Vorasidenib
EMA (1) IDH2 p.R172G Oligodendroglioma Vorasidenib
EMA (1) IDH2 p.R172S Oligodendroglioma Vorasidenib
EMA (1) IDH2 p.R172W Oligodendroglioma Vorasidenib