IDH1/2 in glioma
2 EU-approved indications in glioma need a IDH1/2 result: vorasidenib (1st line) and vorasidenib (any line).
Grade
Line of therapy
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| IDH1/2 mutation2 | ||||
Voranigo | 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 |
Voranigo | 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 |
One approval for Glioma needs no biomarker and applies whatever the result. All approvals for Glioma
See also
Label wording2
The sentence from section 4.1 of the SmPC that each indication above comes from.
- Vorasidenib (Voranigo)
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).
- Vorasidenib (Voranigo)
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).