12:00 AM
Jul 07, 2008
 |  BioCentury  |  Product Development

The 2-day difference

Eisai Co. Ltd. and SuperGen Inc. aren’t expressing concern that Dacogen decitabine missed the primary endpoint of survival benefit in a European Phase III trial to treat myelodysplastic syndromes, as the partners maintain the trial used an outdated protocol. Although it’s unclear whether the negative outcome will affect a planned regulatory resubmission in Europe, the companies expect no changes in prescribing habits in the U.S., where the drug is already approved for MDS.

In the trial, Dacogen plus best supportive care did not show a median overall survival improvement vs. best supportive care alone. The open-label trial, run by the European Organization for the Research and Treatment of Cancer (EORTC), started in 2002 and enrolled 233 elderly patients with MDS.

Patients received 135 mg/m2 Dacogen over three consecutive days, with a treatment limit of eight cycles. Once a patient had a response,...

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