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  • New drug Tibsovo is approved in Korea
  • by Lee, Hye-Kyung | translator Kang, Shin-Kook | May 23, 2024 05:49am
New drug for AML and cholangiocarcinoma
An orphan drug that targets the IDH1-mutation
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 ¡Ã75 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 (2HG) that promotes the
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