Tolero Pharmaceuticals announced that the FDA has granted Orphan Drug designation to alvocidib for the treatment of patients with acute myeloid leukemia (AML). Alvocidib is a multi cyclin-dependent kinase (CDK) small molecule inhibitor.

The submission was based on multiple Phase 2 clinical trials that evaluated alvocidib in about 400 patients with both relapsed/refractory or frontline, previously untreated intermediate and high-risk AML. Alvocidib was evaluated as a single agent as well as in combination with cytarabine and mitoxantrone in these trials.

RELATED: Volasertib Designated Orphan Drug for Acute Myeloid Leukemia

Alvocidib is currently being investigated in a Phase 2 study for the treatment of intermediate and high-risk AML in combination with standard of care agents.

For more information call (801) 285-6003 or visit