The Ministry of Food and Drug Safety (MFDS) announced that it has approved the orphan drug Tibsovo Tab (ivosidenib)' that is being imported by Servier Korea on the 22nd.

The drug is indicated for use in combination with azacitidine for newly-diagnosed acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation in adults aged ≥75 years, or who have comorbidities that preclude the use of intensive induction chemotherapy, or as monotherapy for locally advanced or metastatic cholangiocarcinoma in previously treated adults with IDH1 mutation.

IDH1(Isocitrate Dehydrogenase1) mutation produces an abnormally high amount of a metabolite (R)-2-hydroxyglutarate