Myelodysplastic Syndrome
FDA Accepts sNDA for Alternative Dosing Regimen for Dacogen(R) (decitabine for injection) to Treat Patients with Myelodysplastic Syndromes (MDS)
Published in Medical Letter on the CDC and FDA, July 26th, 2009
Eisai Corporation of North America announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's supplemental new drug application (sNDA) for an alternative five-day dosing regimen for Dacogen(R) (decitabine for injection) to treat patients with myelodysplastic syndromes (MDS). MDS is a potentially life-threatening group of bone marrow diseases that limit the production of functional blood cells.
Currently, Dacogen is approved for use as a three-day regimen, administered at a dose of 15 mg/m2 via continuous IV infusion over three hours repeated every eight hours for three consecutive days per cycle. The cycle is repeated every six...
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