Tibsovo (ivosidenib) [product monograph]. HC.

Regulatory approval published by the Health Canada.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
TIBSOVO (ivosidenib) in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive intensive induction chemotherapy.
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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies