U.S. FDA Approves Eisai MDS Drug Dacogen Five-day Dosing Regimen

Eisai obtained U.S. FDA approval for five-day dosing of Dacogen (decitabine) injection for patients with myelodysplastic syndromes. The new regimen will be administered at a dose of 20 mg continuous intravenous injection over one hour repeated daily for five days per cycle. The cycle is repeated every four weeks. Currently, Dacogen's three-day regimen is administered in an in-patient setting at a dose of 15 mg IV injection over three hours repeated every eight hours for three days per cycle and repeated every six weeks. Eisai hopes the shortened administration time and out patient convenience will increase the number of patients. (Click here for more - Japanese language