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

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 -- 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.

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

Contact: presse@servier.com