Servier receives a positive CHMP opinion for Tibsovo® in IDH1- mutated Acute Myeloid Leukemia (AML) and Cholangiocarcinoma (CCA) patients
Servier, a global pharmaceutical company, 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:
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."
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