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Ilex clofarabine gets user fee extension

Executive Summary

FDA extends review clock for Ilex' pediatric leukemia agent clofarabine by three months to Dec. 30 following submission of additional clinical data. Ilex completed the rolling NDA filing March 29 for priority review, originally setting a Sept. 29 user fee date. Ilex submitted data on 14 additional patients from Phase II trials in acute lymphoblastic leukemia and acute myeloid leukemia, bringing the total number of patients included in the filing to 84. Genzyme, which is seeking regulatory clearance to acquire Ilex, has conservatively projected approval for late 2005...

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