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FDA Approves Five-Day Dosing Regimen for Dacogen(R) (decitabine) for Injection, Offering a New Outpatient Dosing Option for Myelodysplastic Syndromes (MDS)
Date:3/11/2010

e-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.

If myelosuppression is present, subsequent treatment cycles of Dacogen should be delayed until there is a hematologic recovery.

The Dacogen study results, based on International Working Group 2000 Response Criteria, showed that patients experienced an overall response rate (ORR) of 16 percent (complete remission [CR] of 15 percent and a partial response [PR] of 1 percent). In addition, the median time to (CR+PR) response was 162 days and the median duration of (CR+PR) response was 443 days. These results were consistent with the results of the Phase III controlled trial. The highest incidences of Grade 3 or Grade 4 adverse events in the Dacogen arm were neutropenia (37%), thrombocytopenia (24%), and anemia (22%).

"The approval of Dacogen offers doctors and patients the flexibility of choosing the most appropriate dosing regimen for an individual patient," said  Steven C. Sembler, Senior Vice President of Commercial U.S. Pharmaceuticals at Eisai Inc. "This important milestone demonstrates our commitment to furthering Eisai's human health care mission of increasing benefits for patients and their families."


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