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

Comunicati

(Adnkronos) – 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:

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.pdfLogo – https://mma.prnewswire.com/media/1914957/Servier_Logo.jpg
Contact: presse@servier.com

View original content to download multimedia:https://www.prnewswire.co.uk/news-releases/servier-receives-a-positive-chmp-opinion-for-tibsovo-in-idh1-mutated-acute-myeloid-leukemia-aml-and-cholangiocarcinoma-cca-patients-301755348.html