Servier has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for TIBSOVO (ivosidenib tablets) for two indications as a first line treatment, in combination with azacitidine, in patients with previously untreated IDH1-mutated acute myeloid leukemia (AML) and not eligible for intensive chemotherapy, as well as in previously treated, locally advanced or metastatic IDH1-mutated cholangiocarcinoma. TIBSOVO is an inhibitor of the mutated isocitrate dehydrogenase-1 (IDH1) enzyme. TIBSOVO is the first IDH1 mutation specific targeted therapy to be submitted for registration in Europe.
"This MAA submission is a further step towards the availability of TIBSOVO in Europe, a targeted therapy for patients with previously untreated IDH1-mutated acute myeloid leukemia, and previously treated, locally advanced or metastatic IDH1-mutated cholangiocarcinoma – two rare cancers for which therapeutic options are limited," said Claude Bertrand, Executive Vice President R&D of the Servier Group. "We look forward to working with the EMA throughout the evaluation process of TIBSOVO, which is the first IDH1 mutation specific targeted therapy to be submitted in Europe."
"At Servier, we are committed to finding new therapeutic solutions for patients with difficult-to-treat cancers with high unmet medical needs. With this filing submission to the EMA, we hope to soon be able to make TIBSOVO available to patients with newly diagnosed IDH1-mutated AML, and to patients suffering from previously treated, locally advanced or metastatic IDH1-mutated cholangiocarcinoma," explained Dr. Philippe Gonnard, Executive Vice President Global Medical & Patient Affairs of the Servier Group.
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