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Medical Letter on the CDC & FDA

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Breast Cancer



Orphan drug designation granted from U.S. FDA for Efaproxyn



September 5th, 2004

Allos Therapeutics (ALTH) announced that the U.S. Food and Drug Administration (FDA) awarded orphan drug status to the company's lead clinical candidate, Efaproxyn (efaproxiral) for use as an adjunct to whole brain radiation therapy (WBRT) for the treatment of brain metastases in patients with breast cancer.

Efaproxyn is currently being investigated in a phase III clinical trial in this indication at leading cancer centers across North America.

The FDA may award orphan drug designation to drugs that target conditions affecting 200,000 or fewer U.S. patients per year and provide a significant therapeutic advantage over existing treatments.

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Source: Medical Letter on the CDC & FDA (2004-09-05)

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