Regulatory approval

Published by the European Medicines Agency.

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 is written in the approval document as:

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.

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

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