FOR ADULT PATIENTS. It is not known if ONUREG® is safe and effective in children under 18 years of age.

What is ONUREG®?

ONUREG® is the first FDA-approved continued treatment for people with AML who are in first remission

ONUREG® is a prescription medicine used for continued treatment of adults with acute myeloid leukemia (AML) who had a first complete remission (CR) following intensive induction chemotherapy with or without recovery of your blood cell counts, and who are not able to complete intensive curative therapy.

It is not known if ONUREG® is safe and effective in children under 18 years of age.

How does ONUREG® work?

In preclinical studies, ONUREG® stopped AML cells from growing and increasing in number. In these studies, ONUREG® worked by incorporating itself into the DNA and RNA of cancer cells, and this may help reactivate certain genes and help kill the cancer cells.

ONUREG® is given to people in first remission

Red Blood Cell
White Blood Cell
Blast Cell

What are the possible benefits of ONUREG®?

A clinical trial was done to determine the safety and effectiveness of ONUREG®

ONUREG® was studied in 472 people with AML who achieved first remission (had no signs or symptoms of AML)
following intensive induction therapy with or without consolidation therapy, who were 55 years or older, and who
did not proceed to transplant.

  • 238 people were randomly assigned to receive ONUREG®
  • 234 people received placebo
ONUREG® (azacitidine) Rings The main goal of the trial was to determine how much longer adults with AML in first remission could live when taking ONUREG® compared with placebo

People with AML taking ONUREG® lived longer overall
than people taking placebo

Placebo 14.8 MONTHS
Approximately 10 months
difference vs placebo

Overall survival refers to how long people in a clinical trial stayed alive after beginning treatment. The median is the middle number. This means that half of people who took ONUREG® were alive 24.7 months after the beginning of treatment, which is over 2 years.

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