Regulatory approval

Published by the Health Canada. Approved

Health Canada approved 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.

This is written in the approval document as:

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.

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	Acute Myeloid Leukemia	Azacitidine, Ivosidenib
HC (1)	IDH1 p.R132G	Acute Myeloid Leukemia	Azacitidine, Ivosidenib
HC (1)	IDH1 p.R132H	Acute Myeloid Leukemia	Azacitidine, Ivosidenib
HC (1)	IDH1 p.R132L	Acute Myeloid Leukemia	Azacitidine, Ivosidenib
HC (1)	IDH1 p.R132S	Acute Myeloid Leukemia	Azacitidine, Ivosidenib
HC (1)	IDH1 p.R132S	Cholangiocarcinoma	Ivosidenib

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals