Ivosidenib
Ivosidenib (Tibsovo, Les Laboratoires Servier) has 2 EU-approved indications in 2 tumour types. Each needs a biomarker result: IDH1/2 (2).
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Biliary tract cancer1 | |||
IDH1 R132 | Monotherapy | 2L advanced | Cholangiocarcinoma only; After at least one prior line of systemic therapy |
| Acute myeloid leukaemia1 | |||
IDH1 R132 | + azacitidine | 1L | Not eligible to receive standard induction chemotherapy |
Full text of section 4.1 (therapeutic indications)
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). 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).
Label history
3 changes to the Tibsovo label since 2024, none of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes