All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit Know AML.

The AML Hub uses cookies on this website. They help us give you the best online experience. By continuing to use our website without changing your cookie settings, you agree to our use of cookies in accordance with our updated Cookie Policy


Now you can personalise
your AML Hub experience!

Bookmark content to read later

Select your specific areas of interest

View content recommended for you

Find out more

The AML Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the AML Hub cannot guarantee the accuracy of translated content. The AML Hub and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.

Steering CommitteeAbout UsNewsletterContact
You're logged in! Click here any time to manage your account or log out.
You're logged in! Click here any time to manage your account or log out.

Azacitidine tablets (CC-486) have been approved by the European Commission as a maintenance therapy for AML

Jun 24, 2021

Bookmark this article

On June 18, 2021, it was announced that the European Commission (EC) granted full marketing authorization for azacitidine tablets (CC-486) as a maintenance therapy in adult patients with acute myeloid leukemia (AML). This includes patients who have achieved complete remission or complete remission with incomplete blood count recovery following induction therapy with or without consolidation treatment and who are not eligible for, or choose not to proceed to, hematopoietic stem cell transplantation.1

This European Commission marketing authorization approval is valid in all 27 member states of the European Union, as well as Iceland, Liechtenstein, and Norway. It follows the Committee for Medicinal Products for Human Use (CHMP) recommendation and the approval by the U.S. Food and Drug Administration (FDA).

The approvals are based on results from the phase III QUAZAR AML-001 international, randomized, double-blind trial investigating CC486 maintenance versus placebo in patients aged ≥55 years and with newly diagnosed AML. Study participants had intermediate or poor cytogenetics.

Key results

  • Primary endpoint: median overall survival from time of randomization was >2 years (24.7 months) in the CC486 arm compared with 14.8 months for the placebo arm (p = 0.0009).
  • Median relapse-free survival was significantly longer with CC486 than with placebo (10.2 months and 4.8 months, respectively; p < 0.001).
  • Adverse events (AEs):
    • Serious adverse reactions occurred in 15% of patients who received CC-486.
    • The most common AEs in both treatment arms were Grade I or II gastrointestinal events, with the following AEs observed in the CC-486 and placebo arms, respectively: nausea (65%; 24%), vomiting (60%; 10%), diarrhea (50%; 21%), fatigue/asthenia (44%; 25%), constipation (39%; 24%), pneumonia (27%; 17%), abdominal pain (22%; 13%), arthralgia (14%; 10%), decreased appetite (13%; 6%), febrile neutropenia (12%; 8%), dizziness (11%; 9%), and pain in extremity (11%; 5%).
    • In patients who received CC-486, common AEs were new or worsening Grade III or IV neutropenia and thrombocytopenia (49% and 22%, respectively).

Read the AML Hub summary here and view the visual abstract of the QUAZAR AML-001 study, which both highlight the efficacy and safety results.

  1. Business Wire. Bristol Myers Squibb receives European Commission approval for Onureg® (azacitidine tablets) as frontline oral maintenance therapy for adults with acute myeloid leukemia. Published Jun 18, 2021. Accessed Jun 21, 2021.


Subscribe to get the best content related to AML delivered to your inbox