USFDA accepts for Priority review Bristol Myers Squibb application for CC-486 for maintenance treatment in leukemia

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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