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ONUREG® is indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy.

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Disease Overview

AML is a deadly disease with a high risk of relapse even after achieving a CR or CRi1

Because AML cells may still be present during remission, they have the ability to proliferate and cause relapse2

In 764 patients with AML, 60-85 years of age, relapse rates after induction therapy were as follows3*:

~50 ~50%
relapse within 1 year3,4
~80 ~80%
relapse within 5 years

*A study conducted by the German AML Cooperative Group, published in the Journal of Oncology, assessed OS and remission rates in patients (N=2,776) with treatment-naive AML by age and disease-related variables following various induction therapies. 1,336 patients aged 60-85 were randomized, and ultimately 764 patients received induction therapy and were assessed for OS and remission rates. Induction therapy was defined as either TAD-HAM (combination of cytarabine daunorubicin and thioguanine as the first course, followed by cytarabine and mitoxantrone) or HAM-HAM (cytarabine and mitoxantrone as the first and second course).

Overall, 5-year survival rate for AML is 28.7%5

Graph showing 5-year survival rates for AML Graph showing 5-year survival rates for AML

SEER survival rates by time since diagnosis, 2010-2016.

A goal of continued treatment for AML is extending overall survival in patients who have achieved remission6

Potential treatment journey for AML patients who achieve first remission7,8

Potential treatment journey following AML diagnosis
50% to 75% of AML patients do not receive HSCT following induction therapy9‡Continued treatment may provide another option7

In an analysis of the SEER-Medicare 2013-2015 database, 11,142 newly diagnosed adult patients with AML were evaluated and stratified into 2 groups: treatment with chemotherapy (n=4,772) and non-treatment (n=6,370). Within the treatment with chemotherapy group, 55.1% of patients 66 to 70 years of age and 26.6% of patients 71 to 75 years of age went on to receive HSCT.9

While some patients proceed to HSCT, reasons for not receiving transplant may include10:

  • Older age
  • Comorbidities
  • Donor unavailability
  • Patient refusal
  • Worsening performance status
  • Inadequate social support

HSCT, hematopoietic stem cell transplantation.