Ilex begins clofarabine rolling NDA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
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