MGI Pharma says Dacogen injections more effective than supportive care alone

By Elaine Rigoli

Tampa, Fla., April 18 - MGI Pharma, Inc. announced publication of data from a randomized, controlled, phase-3 trial (study 0007) of Dacogen (decitabine) for injection in the journal Cancer.

In the trial of Dacogen versus supportive care conducted in 170 patients with myelodysplastic syndromes, the overall improvement rate for patients who received Dacogen was 30% compared to 7% for those who received supportive care alone, according to a news release.

The response was durable with a median time of 10.3 months, the release said.

All patients who responded to Dacogen treatment became or remained transfusion independent, and cytogenetic complete responses were observed in 35% of patients treated with Dacogen, the release said.

Dacogen is an investigational drug currently under review by the Food and Drug Administration for the treatment of patients with myelodysplastic syndromes.

The Prescription User Fee Act goal date for Dacogen is May 15.

Minneapolis-based MGI Pharma is an oncology- and acute care-focused biopharmaceutical company that acquires, researches, develops and commercializes proprietary products that address the unmet needs of patients.

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