Alvocidib Designated Orphan Drug in AML

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.

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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.

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