MGI Pharma, Inc., an oncology- and acute care-focused biopharmaceutical company, announced that Dacogen (decitabine) for Injection is now commercially available in the United States.
Dacogen was approved by the US Food and Drug Administration (FDA) on May 2, 2006 for the treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British (FAB) subtypes (refractory anaemia, refractory anaemia with ringed sideroblasts, refractory anaemia with excess blasts, refractory anaemia with excess blasts in transformation, and chronic myelomonocytic leukaemia), 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 billion in total revenue by 2010. In addition to Dacogen, MGI Pharma markets Aloxi and Gliadel, and has five ongoing pivotal programs to drive future growth," said Lonnie Moulder, President and CEO of MGI Pharma. "With our field commercial organization now trained, we look forward to discussing the availability of Dacogen with the haematologists and oncologists who treat patients with MDS."
Results from a phase 3 clinical trial of Dacogen demonstrated an overall response rate of 21 per cent 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 per cent 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.
Dacogen may cause fatal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant while using Dacogen. Men should be advised not to father a child while receiving treatment with Dacogen and for 2 months afterwards.
The most commonly occurring adverse reactions with Dacogen include neutropenia (90 per cent), thrombocytopenia (89 per cent), anaemia (82 per cent), pyrexia (53 per cent), fatigue (48 per cent), nausea (42 per cent), cough (40 per cent), petechiae (39 per cent), constipation (35 per cent), and diarrhoea (34 per cent).
MGI Pharma is currently conducting a phase 3 pivotal trial to evaluate Dacogen in patients with AML. Additional phase 2 studies are also underway to evaluate alternative dosing regimens for Dacogen in patients with MDS, AML and chronic myelogenous leukaemia, or CML. A phase 3 European Organization for Research and Treatment of Cancer- (EORTC-) sponsored study of Dacogen in patients with MDS is ongoing in Europe.