Positive CHMP opinion for Tibsovo in IDH1-mutated Acute Myeloid Leukemia and Cholangiocarcinoma patients. Servier.
Servier, a global pharmaceutical company,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: i. 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, ii. 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.
The positive CHMP opinion is based on clinical data from the AGILE (AML) and ClarIDHy (CCA) studies..
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