Posted by Michael Wonder on 01 May 2020
U.S. FDA accepts for priority review Bristol Myers Squibb’s application for CC-486 for maintenance treatment of adult patients in remission with acute myeloid leukaemia
1 May 2020 - Application based on results from the Phase 3 QUAZAR-AML-001 study.
Bristol Myers Squibb today announced that the U.S. FDA has accepted its new drug application for CC-486, an investigational oral hypomethylating agent, for the maintenance treatment of adult patients with acute myeloid leukaemia, who achieved complete remission (CR) or CR with incomplete blood count recovery, following induction therapy with or without consolidation treatment, and who are not candidates for, or who choose not to proceed to, haematopoietic stem cell transplantation.
The FDA granted the application priority review and set a Prescription Drug User Fee Act goal date of 3 September 2020.
