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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 CC‑486 maintenance versus placebo in patients aged ≥55 years and with newly diagnosed AML. Study participants had intermediate or poor cytogenetics.
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