What is the role of azacitidine (Onureg) in the treatment of acute myeloid leukemia (AML)?

Updated: May 26, 2020
  • Author: Karen Seiter, MD; Chief Editor: Emmanuel C Besa, MD  more...
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Answer

In September 2020, the FDA approved an oral formulation of azacitidine (Onureg) for the continued treatment of adult patients with AML who have achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy but are not able to complete intensive curative therapy. Approval was based on results of the phase III QUAZAR AML-001 study, which included patients age 55 or older who were within 4 months of achieving first CR or CRi following intensive induction chemotherapy with or without consolidation treatment and were not candidates for HCT. In patients (n = 238) who received azacitine tablets, 300 mg once daily on days 1 to 14 of each 28-day cycle, median overall survival was 24.7 months, versus 14.8 months in the placebo arm (n= 234)(P=0.0009). [52]


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