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FDA Grants Priority Review to CC-486 for the Treatment of Acute Myeloid Leukemia

The FDA granted priority review to a new drug application (NDA) for CC-486 for the maintenance treatment of adult patients with acute myeloid leukemia (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.1

The FDA has set a prescription drug user fee act (PDUFA) goal date of September 3, 2020.

“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,” Noah Berkowitz, MD, PhD, senior vice president for Global Clinical Development and Hematology…

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