Table 1:
FDA approved clinical therapies for the treatment of newly diagnosed and relapsed/refractory AML. (https://www.cancer.gov/aboutcancer/treatment/drugs/leukemia#3)
| FDA Approved Treatment for AML | |||
|---|---|---|---|
| Drug(s) | Treatment Type | Newly Diagnosed Indication | Relapse or Refractory Indication |
| Cytarabine / Daunorubicin (7+3) (1973) | Cytotoxic Chemotherapy | All adult and pediatric patients | All adult and pediatric patients |
| Bone Marrow Transplantation (1977) | Allogeneic or autologous stem cell transplantation | All patients under the age of 65 years, if donor available | All patients under the age of 65 years, if donor available |
| CPX-351 (2017) | Liposomal cytarabine and daunorubicin fixed combination (5:1 molar ratio) | Newly diagnosed therapy-related AML or AML with myelodysplasia-related changes | |
| Gemtuzumab ozogamycin (2017) | Anti-CD33 antibody–drug conjugate | Adult patients with CD33-positive AML | Patients ≥ 2 years of age with refractory CD33-positive AML |
| Midostaurin (2017) | Multikinase FLT3 inhibitor | Patients with FLT3-mutated AML, in combination with standard induction chemotherapy followed by cytarabine consolidation | |
| Enasidenib (2017) | IDH2 inhibitor | IDH2- mutated newly diagnosed AML | IDH2- mutated refractory AML |
| Glasdegib (2018) | Hedgehog pathway inhibitor | Newly diagnosed AML patients ≥75 years in combination with low-dose cytarabine | |
| Venetoclax (2018) | BCL-2 inhibitor | Newly diagnosed AML patients ≥75 years in combination with azacitidine or decitabine, or low-dose cytarabine | |
| Gilteritinib (2018) | FLT3 inhibitor | Patients with relapsed or refractory FLT3-mutated AML | |
| Ivosidenib (2019) | IDH1 inhibitor | Patients ≥ 75 years old or ineligible to receive high-dose chemotherapy with IDH1- mutated AML | IDH1- mutated refractory AML |
| CC-486 (2020) | Hypomethylating agent (Oral azacitidine) | Patients who previously responded to induction chemotherapy however are unfit for high-dose chemotherapy | |