IDH1/2 in biliary tract cancer

1 EU-approved indication in biliary tract cancer needs a IDH1/2 result: ivosidenib (2nd line, advanced).

Site

Line of therapy

Approved indications, Biliary tract cancer
DrugBiomarker requirementRegimenSettingConditions
IDH1 mutation1
Ivosidenib
Tibsovo
R132
Monotherapy
2L
advanced
Cholangiocarcinoma only; After at least one prior line of systemic therapy

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

See also

Label wording1

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

  1. 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).