Now that the FDA has given its approval for the drug, MGI Pharma will waste no time in making it available to patients with a commercial launch expected during the second quarter of 2006.
“The FDA approval of Dacogen marks an important advancement for patients who suffer from MDS,” said Dr John Bennett, chair of The Myelodysplastic Syndromes Foundation. “Patients with this serious condition are often anemic, experience fatigue and weakness and, in certain cases with an increase in leukemic blast cells, MDS can result in bone marrow failure.”
Results from a phase III clinical trial 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.
Lonnie Moulder, president and CEO of MGI added that the company continues to develop the drug in different indications, including acute myeloid leukemia, chronic myelogenous leukemia, and solid tumors.