# Ivosidenib

Ivosidenib (Tibsovo, Les Laboratoires Servier) has 2 EU-approved indications in 2 tumour types. Each needs a biomarker result: IDH1/2 (2).

## Approved indications

### Biliary tract cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| IDH1 R132 | Monotherapy | 2nd line, advanced | Cholangiocarcinoma only; After at least one prior line of systemic therapy |

### Acute myeloid leukaemia

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| IDH1 R132 | + azacitidine | 1st line | Not eligible to receive standard induction chemotherapy |

## Products

### Tibsovo

- Company: Les Laboratoires Servier
- Target: Mutant IDH1 inhibitor
- Class: Isocitrate dehydrogenase (IDH) inhibitors
- ATC: L01XM02
- EU approval: 4 May 2023
- Label revised: 25 Feb 2026
- Status: orphan medicine
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/tibsovo-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/tibsovo-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/tibsovo

Mechanism (SmPC section 5.1): Ivosidenib inhibits the mutant IDH1 enzyme, reducing 2-hydroxyglutarate levels and restoring cellular differentiation.

## 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)
- **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/drugs/ivosidenib