FDA considers new dose for Esai’s Dacogen

The FDA is reviewing Eisai Corporation of North America's supplemental new drug application for Dacogen (decitabine for injection). The review is for an alternative five-day dosing regimen to treat patients with myelodysplastic syndromes.

Currently, Dacogen is approved for use as a three-day regimen for the bone marrow disease at a dose of 15 mg/m2. The regimen involves continuous IV infusion over three hours repeated every eight hours for three consecutive days, which is then repeated every six weeks. The alternative dose Eisai submitted to FDA is a single daily dose with a reduced administration time.