Regulatory approval
Published by the Health Canada.
Health Canada approved ivosidenib as monotherapy 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 as:
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.
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 | Cholangiocarcinoma | Ivosidenib | |
| Sensitivity (+) | IDH1 p.R132G | Cholangiocarcinoma | Ivosidenib | |
| Sensitivity (+) | IDH1 p.R132H | Cholangiocarcinoma | Ivosidenib | |
| Sensitivity (+) | IDH1 p.R132L | Cholangiocarcinoma | Ivosidenib |