Regulatory approval

Published by the European Medicines Agency. Approved

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.

This is written in the approval document.

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.

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations
Biomarkers
Cancer types
Therapies
Organizations Biomarkers Cancer types Therapies
EMA (1) IDH1 p.R132C Cholangiocarcinoma Ivosidenib
EMA (1) IDH1 p.R132G Cholangiocarcinoma Ivosidenib
EMA (1) IDH1 p.R132H Cholangiocarcinoma Ivosidenib
EMA (1) IDH1 p.R132L Cholangiocarcinoma Ivosidenib
EMA (1) IDH1 p.R132S Cholangiocarcinoma Ivosidenib

Contributions

Date Contributor Description
2024-10-20 Van Allen lab Adding EMA approvals for use to database
2023-05-04 European Medicines Agency Indication received approval from the European Commission.