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 indications4

DrugBiomarker requirementRegimenSettingConditions
Biliary tract cancer1
Ivosidenib
Tibsovo
R132
Monotherapy
2L
advanced
Cholangiocarcinoma only; After at least one prior line of systemic therapy
Glioma2
Vorasidenib
Voranigo
IDH1 R132 or IDH2 R172
Monotherapy
1L
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
Vorasidenib
Voranigo
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 leukaemia1
Ivosidenib
Tibsovo
R132
+ azacitidine
1L
Not eligible to receive standard induction chemotherapy

IDH1/2 by tumour

Label wording4

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

  1. Vorasidenib (Voranigo)
    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).
  2. Vorasidenib (Voranigo)
    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).
  3. 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).
  4. Ivosidenib (Tibsovo)
    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).