Servier receives a positive CHMP opinion for Tibsovo® in IDH1-mutated Acute Myeloid Leukemia (AML) and Cholangiocarcinoma (CCA) patients

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• 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:

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• 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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