Ilex Expects Priority Review For Clofarabine; Genzyme Sees Longer Timeframe
This article was originally published in The Pink Sheet Daily
Genzyme, which is slated to acquire Ilex, apparently believes FDA may require additional data for the pediatric leukemia drug. Updated data from the two pivotal Phase II studies will be presented at the American Society of Clinical Oncology in June.
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Ilex submits data on 14 additional patients with acute lymphoblastic and acute myeloid leukemia to FDA, extending the user fee date by three months to Dec. 30. The company completed the original rolling NDA March 29.
The Irvine, Calif., firm also plans sNDAs for a colorectal cancer claim and an oral formulation of the leucovorin relative.