« Back

FDA approves five-day dosing regimen of Eisai's Dacogen for MDS

Friday, March 12 2010 | Comments

---

What's This? The Food and Drug Administration approved Eisai Inc.'s Dacogen (decitabine) 20 mg/m2 for injection to be administered in a five-day dosing regimen for the treatment of patients with myelodysplastic syndromes (MDS), a group of potentially life-threatening bone marrow diseases that alters the production of functional blood cells.

Eisai said Dacogen is the only hypomethylating agent approved for a five-day dosing regimen. The new product can be administered in an outpatient setting at a dose of 20 mg/m2 as a continuous intravenous (IV) infusion over one hour for five days per cycle, which are repeated every four weeks. The drug is already approved as a three-day regimen administered in an inpatient setting at a dose of 15 mg/m2 continuous IV infusion over three hours and repeated every eight hours for three days per cycle, with the cycle repeated every six weeks.

The company said the safety and efficacy of the new Dacogen regimen was evaluated in three trials that included patients with any of the French-American-British subtypes of MDS.

However, it was the open-label, single-arm, Phase II study that formed the basis of the supplemental New Drug Application. In the trial, 99 patients with advanced-stage MDS received Dacogen at a continuous IV dose of 20 mg/m2 for five days every four weeks. The study results showed that the patients treated with Dacogen experienced an overall response rate of 16 percent (complete remission of 15 percent and a partial response of 1 percent). In addition, the median time to an overall response was 162 days, and the median duration of response was 443 days.

The findings were consistent with the results of a Phase III controlled trial, Eisai said.

Dacogen was developed through a Phase III study by SuperGen Inc. and partnered to MGI Pharma, which was later acquired by Eisai Co. Ltd.

Print  |  E-mail