Regulatory approval

Published by the Health Service Executive. Approved

As monotherapy for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated with at least one prior line of systemic therapy.

This is written in the approval document.

Reimbursement

CDS

Citation

Ivosidenib Therapy, 2025, version number 1a, viewed 02/08/2026, https://healthservice.hse.ie/documents/6654/901_v1a_Ivosidenib.pdf

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations Biomarkers Cancer types Therapies
HSE (1) IDH1 p.R132C Cholangiocarcinoma Ivosidenib
HSE (1) IDH1 p.R132G Cholangiocarcinoma Ivosidenib
HSE (1) IDH1 p.R132H Cholangiocarcinoma Ivosidenib
HSE (1) IDH1 p.R132L Cholangiocarcinoma Ivosidenib
HSE (1) IDH1 p.R132S Cholangiocarcinoma Ivosidenib