# IDH1/2

4 EU-approved indications of 2 drugs need a IDH1/2 result, in 3 tumour types, most of them in glioma, acute myeloid leukaemia and biliary tract cancer.

## Approved indications by tumour

### Biliary tract cancer

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Ivosidenib](https://oncolabels.com/drugs/ivosidenib) (Tibsovo) | IDH1 R132 | Monotherapy | 2nd line, advanced | Cholangiocarcinoma only; After at least one prior line of systemic therapy |

### Glioma

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Vorasidenib](https://oncolabels.com/drugs/vorasidenib) (Voranigo) | IDH1 R132 or IDH2 R172 | Monotherapy | 1st 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 Ambiguous in the label (requirement): check the SmPC. |
| [Vorasidenib](https://oncolabels.com/drugs/vorasidenib) (Voranigo) | 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 |

### Acute myeloid leukaemia

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Ivosidenib](https://oncolabels.com/drugs/ivosidenib) (Tibsovo) | IDH1 R132 | + azacitidine | 1st line | Not eligible to receive standard induction chemotherapy |

## Label wording

- **Vorasidenib** (Voranigo), Glioma, 1st line: “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).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/voranigo-epar-product-information_en.pdf)
- **Vorasidenib** (Voranigo), Glioma, any line: “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).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/voranigo-epar-product-information_en.pdf)
- **Ivosidenib** (Tibsovo), Acute myeloid leukaemia, 1st line: “Tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive standard induction chemotherapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tibsovo-epar-product-information_en.pdf)
- **Ivosidenib** (Tibsovo), Biliary tract cancer, 2nd line, advanced: “Tibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tibsovo-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/biomarkers/idh1-2