Bristol Myers Squibb announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for CC-486 for the maintenance treatment of adults in remission with acute myeloid leukemia (AML).

CC-486 is an investigational oral hypomethylating agent, for the maintenance treatment of adult patients with AML, who achieved complete remission (CR) or CR with incomplete blood count recovery (CRi), following induction therapy with or without consolidation treatment, and who are not candidates for, or who choose not to proceed to, hematopoietic stem cell transplantation.

The FDA granted the application Priority Review and set a Prescription Drug User Fee Act (PDUFA) goal date of September 3, 2020.

The NDA submission was based on the efficacy and safety results of the pivotal Phase 3 QUAZAR? AML-001 study, which met the primary endpoint of improved overall survival for patients receiving AML maintenance treatment with CC-486 versus placebo.

“Often, newly diagnosed adult patients with AML achieve a complete response with induction therapy, however many patients will relapse and experience a poor outcome. Patients in remission are seeking treatment options that decrease the likelihood of relapse and extend overall survival,” said Noah Berkowitz, M.D., Ph.D., senior vice president, Global Clinical Development, Hematology, Bristol Myers Squibb. “Today’s acceptance of our submission for CC-486 represents an important step towards a potential new maintenance treatment to address an urgent medical need for AML patients and we look forward to working with the FDA during its review of CC-486.”

CC-486 is an investigational therapy that is not approved for any use in any country.

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