MGI Pharma debuts Dacogen inj in USA

MGI Pharma says that Dacogen (decitabine) for injection is now commercially-available in the USA. Dacogen was approved by the Food and Drug Administration on May 2, for the treatment of patients with myelodysplastic syndromes including previously treated and untreated, de novo and secondary MDS of all French-American-British (FAB) subtypes (refractory anemia, refractory anemia with ringed sideroblasts, with excess blasts and with excess blasts in transformation, and chronic myelomonocytic leukemia), and Intermediate-1, Intermediate-2, and High-Risk International Prognostic Scoring System (IPSS) groups.

"In line with our strategy, MGI Pharma continues to expand its presence in oncology and acute care. The introduction of Dacogen is a significant step in our penetration of these markets and in our path to generating $1.0 billion in total revenue by 2010," said the firm's chief executive, Lonnie Moulder.

Results from a Phase III clinical trial of the drug demonstrated an overall response rate of 21% in Dacogen-treated patients considered evaluable for response, defined as those patients with pathologically confirmed MDS at baseline who received at least two cycles of treatment, compared to 0% in the supportive care arm. All patients who responded to Dacogen treatment became or remained transfusion independent during the time of the response.