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.

Therapeutic response

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

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