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Decitabine approvable for myelodysplastic syndromes, FDA says

Issue: October 1, 2005

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The FDA has deemed decitabine injection (Dacogen; MGI Pharma, Super Gen) approvable for the treatment of myelodysplastic syndromes.

The drug’s approval is pending the FDA’s review of an analysis of the transfusion requirements of patients enrolled in a completed phase-3 trial. The FDA will also review submission of other information, including labeling requirements.

“[We are] prepared to launch Dacogen injection upon final FDA approval,” said Lonnie Moulder, president and chief executive officer of MGI Pharma.

In previous studies, decitabine injection has demonstrated activity in several hematological malignancies as well as solid tumors. Future trials will evaluate the agent’s efficacy in patients with acute mye-loid leukemia. Additional studies are underway to evaluate alternative dosing regimens.