FDA approves Dacogen for MDS
US companies MGI Pharma and SuperGen say that the Food and Drug Administration has granted approval for their co-developed drug Dacogen (decitabine) for injection. The compound is indicated for the treatment of patients with myelodysplastic syndromes.
The approval is based on the results of a Phase III trial of the drug which demonstrated a 21% overall response rate in the treatment arm, in comparison with the 0% response seen in patients who only received supportive care. In addition, patients who responded to treatment became or remained transfusion-independent while receiving the drug.
John Bennett, chairman of the Myelodysplastic Foundation, commented that the FDA's approval of the drug was an important step forward for MDS sufferers. MGI Pharma added that it would make the product commercially available during the second quarter of this year.
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