The US FDA has approved Dacogen of MGI pharma and SuperGen for Injection. Dacogen is indicated for treatment of patients with MDS including previously treated and untreated, de novo, and secondary MDS of all 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 IPSS groups. MGI pharma plans to make Dacogen commercially available during the second quarter of 2006.
"The FDA approval of Dacogen marks an important advancement for patients who suffer from MDS," said John M. Bennett, Chair of The myelodysplastic syndromes foundation. "Patients with this serious condition are often anaemic, experience fatigue and weakness and, in certain cases with an increase in leukemic blast cells, MDS can result in bone marrow failure." he added.
According to the release, results from a phase 3 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.
"The approval of Dacogen demonstrates MGI pharma's ability to identify, acquire, develop, and register promising products," said Lonnie Moulder, president and CEO of MGI pharma. "We look forward to providing clinicians with an effective therapy to offer their MDS patients. MGI pharma is committed to continuing the development of Dacogen for patients with acute myeloid leukaemia, chronic myelogenous leukaemia, and solid tumours, in addition to developing alternative dosing regimens for patients with MDS," he added.