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Ilex Expects Priority Review For Clofarabine; Genzyme Sees Longer Timeframe

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Ilex believes its pediatric leukemia agent clofarabine will receive a priority review from FDA, setting the user fee date at Sept. 29.

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Ilex clofarabine gets priority review

FDA grants Ilex' pediatric leukemia agent clofarabine priority review status, the firm announces June 3. Ilex completed its rolling submission of the oncologic March 29 for treatment of refractory or relapsed acute lymphoblastic and acute myeloid leukemia, setting a user fee date of Sept. 29. Genzyme, which is acquiring Ilex, has projected approval at the end of 2005 because of its expectation that FDA will require further studies or data. The NDA is based on two ongoing Phase II monotherapy trials (1Pharmaceutical Approvals Monthly April 1, 2004, p. 10)....

Ilex begins clofarabine rolling NDA

Ilex Oncology commences clofarabine rolling NDA for treatment of refractory or relapsed acute leukemia in children with submission of pharmacology/toxicology data, the firm announces Oct. 22. The firm expects to complete the remainder of the application (clinical and CMC) in the first half of 2004. The filing will be based on ongoing Phase II studies in acute lymphoblastic and acute myelogenous leukemia. Interim Phase II data presented at the American Society of Clinical Oncology in May show an overall response rate of 28% in pretreated children with ALL or AML. Clofarabine was granted fast track status in September for ALL and has orphan drug status for ALL and AML in both adult and pediatric populations

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Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011

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