Dacogen was approved by the FDA on May 2, 2006 for the treatment of patients with the disorder.
Results from a phase III 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 MDS at baseline who received at least 2 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.
“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 billion in total revenue by 2010,” said Lonnie Moulder, president and CEO of MGI Pharma.