MGI Pharma says Dacogen available commercially in United States

By E. Janene Geiss

Philadelphia, May 26 - MGI Pharma, Inc. announced Friday that Dacogen (decitabine) for injection is now commercially available in the United States.

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 myelodysplastic syndromes of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation and chronic myelomonocytic leukemia), and Intermediate-1, Intermediate-2, and High-Risk International Prognostic Scoring System groups, according to a company news release.

"The introduction of Dacogen is a significant step in our penetration of [oncology] markets and in our path to generating $1 billion in total revenue by 2010," Lonnie Moulder, president and chief executive officer, said in the release.

Results from a phase 3 clinical trial of Dacogen demonstrated an overall response rate of 21% in Dacogen-treated patients considered evaluable for response, defined as those patients with pathologically confirmed myelodysplastic syndromes 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. It is recommended that patients be treated with Dacogen for a minimum of four cycles, and treatment may continue as long as the patient continues to benefit, officials said.

MGI Pharma is conducting a phase 3 pivotal trial to evaluate Dacogen in patients with acute leukemia. Additional phase 2 studies also are underway to evaluate alternative dosing regimens for Dacogen in patients with myelodysplastic syndromes, acute leukemia and chronic myelogenous leukemia. A phase 3 European Organization for Research and Treatment of Cancer-sponsored study of Dacogen in patients with myelodysplastic syndromes is ongoing in Europe.

MGI Pharma is a Minneapolis oncology- and acute care-focused biopharmaceutical company.

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