BMS Files NDA for Leukemia Drug

FDA has accepted for review a Bristol Myers Squibb NDA for CC-486, an investigational oral hypomethylating agent for the maintenance treatment of adult patients with acute myeloid leukemia (AML). The drug is intended for patients 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 hematopoietic stem cell transplantation. The company says the submission is based on data from the 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. The agency has set a user fee review action target date of 9/3.

CC-486 incorporates into DNA and RNA, the company says. “The main mechanism of action is thought to be hypomethylation of DNA, as well as direct cytotoxicity to abnormal hematopoietic cells in the bone marrow,” it says.