Regulatory approval

Published by the Health Canada. Approved

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.

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 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