Posted by Michael Wonder on 10 Mar 2022
Servier submits a marketing authorisation application to the EMA for Tibsovo (ivosidenib) for patients with IDH1 mutated acute myeloid leukaemia and cholangiocarcinoma
10 March 2022 - The submission covers countries of the European Union as well as Iceland, Liechtenstein and Norway.
Servier today announced that it has submitted a marketing authorisation application to the EMA for Tibsovo (ivosidenib) for two indications as a first-line treatment, in combination with azacitidine, in patients with previously untreated IDH1 mutated acute myeloid leukaemia and not eligible for intensive chemotherapy, as well as in previously treated, locally advanced or metastatic IDH1 mutated cholangiocarcinoma.
