The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Celator Pharmaceuticals’ investigational agent CPX-351, a liposomal formulation of cytarabine:daunorubicin, for the treatment of elderly patients with secondary acute myeloid leukemia.
The FDA established the Fast Track designation process to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
A phase III study comparing CPX-351 to the current standard of care has completed enrollment. Induction response rate data are expected to be available in the second quarter of 2015, and overall survival data, the primary endpoint of the study, are expected in early 2016. ■