# IDH1/2 in acute myeloid leukaemia

1 EU-approved indication in acute myeloid leukaemia needs a IDH1/2 result: ivosidenib (1st line).

## Approved indications

### IDH1 mutation

| 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

- **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)

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/tumours/acute-myeloid-leukaemia/idh1-2