IDH1/2 in acute myeloid leukaemia

1 EU-approved indication in acute myeloid leukaemia needs a IDH1/2 result: ivosidenib (1st line).
Approved indications, Acute myeloid leukaemia
DrugBiomarker requirementRegimenSettingConditions
IDH1 mutation1
Ivosidenib
Tibsovo
R132
+ azacitidine
1L
Not eligible to receive standard induction chemotherapy

2 approvals for AML need no biomarker and apply whatever the result. All approvals for AML

See also

Label wording1

The sentence from section 4.1 of the SmPC that each indication above comes from.

  1. Ivosidenib (Tibsovo)
    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).