FDA grants CC-486 priority review for the treatment of adult patients with AML

On May 1, 2020, the U.S. Food and Drug Administration (FDA) accepted a new drug application (NDA) and granted priority review to CC-486, an oral formulation of the hypomethylating agent azacitidine, for maintenance treatment of adult patients with acute myeloid leukemia (AML).

The NDA was based on the results of the phase III QUAZAR AML-001 study on patients with AML in complete remission (CR) or CR with incomplete blood count recovery (CRi) after induction therapy (with or without consolidation), who do not proceed to hematopoietic stem cell transplantation. The study showed a significant improvement in overall survival and relapse-free survival for patients receiving CC-486 maintenance treatment in comparison to patients in the placebo group. No unexpected adverse events were observed. Data from this trial were presented at the 61^st American Society of Hematology (ASH) meeting by  Andrew Wei, read more here.

The oral formulation of CC-486 allows for extended exposure to the drug, prolonging the therapeutic activity.