Posted by Michael Wonder on 26 Feb 2023
Servier receives a positive CHMP opinion for Tibsovo in IDH1 mutated acute myeloid leukaemia and cholangiocarcinoma patients
24 February 2023 - The positive CHMP opinion is based on clinical data from the AGILE (in AML) and ClarIDHy (in CCA) studies.
Servier today announced that the CHMP of the EMA has adopted a positive opinion and recommended granting a marketing authorisation for Tibsovo (ivosidenib tablets) - an inhibitor of the mutated isocitrate dehydrogenase-1 (IDH1) enzyme - for two indications.
