New drugs approved for acute myeloid leukemia (AML) in 2018.

Acute myeloid leukemia (AML) is a hematopoietic stem cell disorder, that is characterized by the clonal expansion of myeloid blasts and suppression of normal hematopoiesis. The 3+7 regimen is the backbone of standard first-line induction therapy among young/fit patients. However, in elderly and/or unfit patients with newly diagnosed AML, who cannot receive intensive chemotherapy, low-dose cytarabine (LDAC) or hypomethylating agents (HMAs; azacitidine or decitabine) are the treatment options, which generally cannot induce durable responses. Among young/fit patients, for high-risk disease in first remission, or in cases with relapsed/refractory AML (RRAML), allogeneic stem cell transplantation (ASCT) should be performed when complete remission is achieved. However, since AML is primarily a disease of the elderly, neither intensive chemotherapy nor ASCT can be generally tolerated in most cases. There is clearly a need for new treatment options in elderly and young/unfit patients who cannot receive intensive chemotherapy. The discovery of novel molecular genetic markers (e.g. FMS-like tyrosine kinase 3 (FLT3), isocitrate dehydrogenase 1 (IDH1), isocitrate dehydrogenase 2 (IDH2), etc.) resulted in the development of new therapeutic options in AML. This review mainly focuses on 4 targeted therapy agents; glasdegib and venetoclax used in combination treatment with LDAC or HMAs among newly diagnosed cases with AML and ivosidenib and gilteritinib as monotherapy in the treatment of RRAML, which were all approved by the United States Food and Drug Administration (FDA) in 2018.