Vorasidenib

Vorasidenib (Voranigo, Les Laboratoires Servier) has 2 EU-approved indications in 1 tumour type. Each needs a biomarker result: IDH1/2 (2).
Approved indications of Vorasidenib
Biomarker requirementRegimenSettingConditions
Glioma2
IDH1 R132 or IDH2 R172
Monotherapy
1L
Grade 2 only; After surgical intervention only; Aged 12 years and older; weighing at least 40 kg; not in immediate need of radiotherapy or chemotherapy
IDH2 R172
Monotherapy
Any line
Grade 2 only; After surgical intervention only; Aged 12 years and older; weighing at least 40 kg; not in immediate need of radiotherapy or chemotherapy
Full text of section 4.1 (therapeutic indications)

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).

Label history

3 changes to the Voranigo label since 2026, none of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes