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

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:

* 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

* 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 Groups 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 CHMPs 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.

PDF – https://mma.prnewswire.com/media/2009347/PR___Servier.pdf

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Contact: presse@servier.com

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