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FDA Grants Orphan Drug Designation to Alvocidib for the Treatment of Acute Myeloid Leukemia

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The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to alvocidib, a potent cyclin-dependent kinase small-molecule inhibitor, for the treatment of patients with acute myeloid leukemia (AML). The agent is being tested in patients with intermediate- or high-risk AML, who typically have a poor prognosis due to limited treatment options.

Alvocidib has been evaluated in multiple phase II clinical trials involving approximately 400 patients with both relapsed/refractory or front-line, previously untreated intermediate- and high-risk AML. In these trials, the drug has been evaluated as a single agent as well as in combination with approved agents including cytarabine and mitozantrone. The agent is currently being investigated in a phase II study for the treatment of intermediate- and high-risk AML in combination with standard of care agents.

The FDA grants Orphan Drug designation to promote the development of agents that target conditions affecting 200,000 or fewer U.S. patients annually and that are expected to provide significant therapeutic advantage over existing treatments.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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