Marker Therapeutics Inc (MRKR)

[hanscott]

This is nice to hear. 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.

patients receiving AML maintenance treatment with CC-486, an investigational oral hypomethylating agent, versus placebo.

At 1 year, 47% of patients were free of relapse in the CC-486 arm compared with 29% in the placebo group. Notably, the benefits in both RFS and OS were seen across key prognostic AML subgroups.