Regulatory approval
Published by the Health Canada.
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
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | IDH1 p.R132C | Acute Myeloid Leukemia | Azacitidine, Ivosidenib | |
| Sensitivity (+) | IDH1 p.R132G | Acute Myeloid Leukemia | Azacitidine, Ivosidenib | |
| Sensitivity (+) | IDH1 p.R132H | Acute Myeloid Leukemia | Azacitidine, Ivosidenib | |
| Sensitivity (+) | IDH1 p.R132L | Acute Myeloid Leukemia | Azacitidine, Ivosidenib | |
| Sensitivity (+) | IDH1 p.R132S | Acute Myeloid Leukemia | Azacitidine, Ivosidenib | |
| Sensitivity (+) | IDH1 p.R132S | Cholangiocarcinoma | Ivosidenib |