Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that IDH1 p.R132S status confers therapeutic sensitivity to Ivosidenib in patients with Cholangiocarcinoma.
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 statement is based on a regulatory approval from the European Medicines Agency:
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.