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A five-day treatment regime for Dacogen, a drug designed to manage and combat myelodysplastic syndromes that hamper the normal production of blood cells, has been approved by the Food and Drug Administration.
The treatment, the only of its kind to be approved over such a period, will be administered to outpatients by means of a 20 mg/m2 continuous IV infusion over one hour, repeated daily for five days per cycle, then repeated again every four weeks.
A three-day regime, in which patients receive a 15 mg/m2 continuous IV infusion over three hours, repeated every eight hours for three days per cycle on a six-week recurring basis, had already been approved.
Makers Eisai claimed the new rules would offer doctors an increased range of treatment options for their patients.
Steven C. Sembler, senior vice president of commercial US pharmaceuticals at the company, said: “The approval of Dacogen offers doctors and patients the flexibility of choosing the most appropriate dosing regimen for an individual patient. This important milestone demonstrates our commitment to furthering Eisai’s human health care mission of increasing benefits for patients and their families.”
Copyright Press Association 2010