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. Fast Track designation facilitates meetings with FDA to discuss all aspects of development to support approval.
It also provides the opportunity to submit sections of a New Drug Application (NDA) on a rolling basis, where FDA may review portions of the NDA as they are received instead of waiting for the entire NDA submission. In addition, a Fast Track designated product could be eligible for priority review if supported by clinical data at the time of NDA submission.
"We are pleased that FDA has granted Fast Track status for CPX-351 for the treatment of elderly patients with secondary AML," said Scott Jackson, CEO of Celator Pharmaceuticals. "Our ongoing phase III study in these patients has completed enrollment, and we expect induction response rate data to be available in the second quarter of this year, and to have overall survival data, the primary endpoint of the study, in the first quarter of 2016. If our phase III study, comparing CPX-351 to the current standard of care, is successful, the Fast Track designation may provide an added benefit of facilitating the NDA review process."