- Tibsovo® (ivosidenib tablets) is the first IDH1 inhibitor recommended for approval in Europe
- The positive CHMP opinion is based on clinical data from the AGILE (in AML) and ClarIDHy (in CCA) studies
PARIS, Feb. 24, 2023 /PRNewswire/ — Servier, a global pharmaceutical company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting a marketing authorization for Tibsovo® (ivosidenib tablets) – an inhibitor of the mutated isocitrate dehydrogenase-1 (IDH1) enzyme – for two indications:
- 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.