Submission of Five-Day Dosing Regimen sNDA Targeted for Fiscal Year-end
WOODCLIFF LAKE, N.J., July 1, 2008 /PRNewswire/ -- Eisai Corporation of North America today announced the preliminary efficacy data from a trial initiated in 2002 comparing Dacogen(R) (decitabine) to Best Supportive Care (BSC) in elderly patients with myelodysplastic syndromes (MDS). The data did not demonstrate a statistically significant advantage of Dacogen treatment on median overall survival. However, response rates were similar to those observed in other clinical trials of Dacogen in patients with MDS. In the trial, conducted by the European Organisation for the Research and Treatment of Cancer (EORTC), Dacogen was administered on a three-day dosing schedule. In this study, the number of treatment cycles was limited. MDS is a potentially life-threatening group of bone marrow diseases that limit the production of functional blood cells.
Subsequent to database lock and the completion of data analysis, comprehensive results of the study, including secondary efficacy endpoints and safety data, will be presented by EORTC at an upcoming scientific forum.
Eisai plans to submit a supplemental New Drug Application (sNDA) with
the U.S. Food and Drug Administration by the end of the fiscal year for a
five-day regimen for Dacogen. The sNDA will be based on a North American,
multi-center, open-label, single arm Phase II trial (DACO-020) in which
patients received Dacogen every day for five days. The regimen was repeated
every four weeks with no limit on the number of treatment cycles that
patients could receive as long as they received clinical benefit or until
their disease progressed. Median survival at the time of data analysis was
19.4 months and the one-year survival rate for patients treated with
Dacogen was 66 percent. An overall complete response rate of 32 percent
(International Working Group 2006 C
|SOURCE Eisai Corporation of North America|
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