March 12, 2010
Five-day dosing regimen for Dacogen approved for myelodysplastic syndromes (MDS)The FDA has approved a five-day dosing regimen for Dacogen (decitabine for injection, from Eisai) to treat patients with myelodysplastic syndromes (MDS). This dosing regimen provides the option of outpatient administration of Dacogen at a dose of 20mg/m2 by continuous 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 inpatient setting at a dose of 15mg/m2 by continuous IV infusion over three hours repeated every eight hours for three days per cycle and repeated every six weeks.
This approval was based on data from three multicenter, open-label, single-arm studies that showed that patients treated with the Dacogen five-day regimen experienced an overall response rate of 16% (complete remission [CR] of 15% and a partial response [PR] of 1%). Additionally the median time to (CR+PR) response was 162 days and the median duration of (CR+PR) response was 443 days.
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