Regulatory approval

Published by the Health Canada. Approved

TIBSOVO (ivosidenib) 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.

This is written in the approval document.

Citation

Servier Canada Inc. Tibsovo (ivosidenib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00076398.PDF. Published July 2024. Accessed June 2025.

Therapeutic response

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

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