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The U.S. Food and Drug Administration has ordered Genzyme Corp. to perform an additional study before the regulator will consider expanding approval for the company’s leukemia drug, Clolar.
The drug is currently approved for the treatment of pediatric-acute lymphoblastic leukemia (ALL) in patients who have relapsed or have refractory disease after at least two prior treatments. Genzyme is seeking approval for Clolar to treat adult myeloid leukemia (AML).
The FDA’s Oncologic Drugs Advisory Committee said the Genzyme study was insufficient and that a randomized, controlled trial is needed to support the additional therapeutic indication. The committee voted 9-3 in favor of those findings.
“The panel indicated that it wasn’t an easy decision to vote for a randomized trial, as Clolar was clearly active in these patients,” said Mark Enyedy, president of Genzyme Oncology and Multiple Sclerosis.
The Genzyme study analyzed 112 adult AML patients aged 60 years and older who had unfavorable prognostic factors.
Genzyme officials said patients in the trial had a 45.5 percent overall remission rate, adding that remission rates were consistent regardless of the type or number of unfavorable risk factors. But the study did not include a control group that was receiving a placebo.
Genzyme also is currently conducting a randomized Phase 3 trial with Clolar, in combination with another drug which is now used as a stand-alone therapy, in relapsed and refractory adult AML patients at least 55 years old. But results are not expected until 2011.
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