Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a five-day dosing regimen for Dacogen® (decitabine) for Injection to treat patients with myelodysplastic syndromes (MDS), a group of bone marrow diseases that alter the production of functional blood cells.
The new outpatient dosing option provides physicians and patients with the flexibility of a dosing regimen with a reduced infusion time. Dacogen is the only hypomethylating agent approved for a five-day dosing regimen. The new regimen will be administered at a dose of 20 mg/m2 continuous intravenous (IV) infusion over one hour repeated daily for five days per cycle. The cycle is repeated every four weeks.
The previously approved Dacogen three-day regimen is administered in an in-patient setting at a dose of 15 mg/m2 continuous IV infusion over three hours repeated every eight hours for three days per cycle and repeated every six weeks.
Three open-label, single-arm, multicenter studies were conducted to evaluate the safety and efficacy of Dacogen in MDS patients with any of the French-American-British (FAB) subtypes. In one study, 99 patients with International Prognostic Scoring System (IPSS) Intermediate-1, Intermediate-2, or high-risk prognostic scores received Dacogen by IV infusion at a dose of 20 mg/m2 continuous IV infusion over one hour repeated daily for five days per cycle. The cycle is repeated every four weeks.