Regulatory approval
Published by the European Medicines Agency.
The European Medicines Agency (EMA) has authorized ivosidenib as a monotherapy for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 variant who were previously treated with at least one prior line of systemic therapy.
This is written in the approval document as:
Tibsovo 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
Les Laboratoires Servier. Tibsovo (ivosidenib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/tibsovo-epar-product-information_en.pdf. Revised January 2024. Accessed March 23, 2024.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 | |
| Sensitivity (+) | IDH1 p.R132S | Cholangiocarcinoma | Ivosidenib |