Ilex clofarabine gets priority review
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
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)....