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Genzyme receives "complete response" letter for Clolar

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA has issued a "complete response" letter for Genzyme's sNDA for use of Clolar (clofarabine) in previously untreated older adult patients with acute myeloid leukemia, the firm announced Oct. 6. FDA's Oncologic Drugs Advisory Committee voted in September that data from a randomized, controlled trial was necessary to establish safety and efficacy in the proposed adult AML indication (1"The Pink Sheet," Sept. 7, 2009). FDA's letter recommends Genzyme conduct such a trial. Drug sponsors seeking approval for elderly AML have argued that randomized trials are difficult to conduct in the setting, and Genzyme sought approval based on a single-arm trial. The company is already conducting a randomized, placebo-controlled Phase III trial of clofarabine plus cytarabine in relapsed and refractory AML patients over 55, with results expected in 2011. Genzyme plans to meet with FDA to discuss whether the additional study may satisfy regulatory requirements. Clolar is already approved for pediatric ALL

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