Skip to main content

Table 2 Approval status for azacitidine and decitabine in MDS and AML

From: A clinical-molecular update on azanucleoside-based therapy for the treatment of hematologic cancers

  Azacitidine (Vidaza) Decitabine (Dacogen)
  MDS AML MDS AML
USA (FDA) All subtypes AML 20–30 % blasts (formerly RAEB-t) All subtypes AML <30 % blasts (formerly RAEB-t)
 Dose 75 mg/m2 s.c. days 1–7 q28 75 mg/m2 s.c. days 1–7 q28 15 mg/m2 i.v. 3× daily days 1–3 q42 or 20 mg/m2 i.v. days 1–5 q28 15 mg/m2 i.v. 3× daily days 1–3 q42 or 20 mg/m2 i.v. days 1–5 q28
Europe (EMA) INT2/high-risk MDS according to IPSS, CMML 10–29 % blasts, not eligible for allogeneic SCT AML ≥65 years regardless of blast counts, not eligible for allogeneic SCT Not approved AML ≥65 years not candidates for standard induction chemotherapy
 Dose 75 mg/m2 s.c. days 1–7 q28 75 mg/m2 s.c. days 1–7 q28 n/a 20 mg/m2 i.v. days 1–5 q28