- in combination with azacitidine, for the treatment of adult patients with newly diagnosed IDH1-mutated Acute Myeloid Leukemia and not eligible for standard induction chemotherapy,
- in monotherapy, for the treatment of adult patients with locally advanced or metastatic IDH1-mutated Cholangiocarcinoma, previously treated by at least one prior line of systemic therapy.
Claude Bertrand, Executive Vice President R&D of Servier, said: “The positive CHMP opinion is a further step towards the availability, in the European Union, of Tibsovo® which is the first IDH1 inhibitor to be recommended for approval in Europe for patients with Acute Myeloid Leukemia and Cholangiocarcinoma for whom therapeutic options are very limited. Tibsovo® is an illustration of the Group’s transformation and commitment in oncology which focuses its research on hard-to-treat cancers with the development of targeted therapies being a promising path for patients.”
The positive CHMP opinion is based on clinical data from the AGILE (AML) and ClarIDHy (CCA) studies.
The CHMP’s positive opinion on Tibsovo® in IDH1 mutated AML and CCA patients will be referred to the European Commission (EC) which will deliver a final decision in the coming months. The decision will be applicable to all 27 EU member states plus Iceland, Norway, Northern Ireland and Liechtenstein.
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