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Sunesis Pharmaceuticals(SNSSD_) announced that vosaroxin, the company's lead drug candidate, has been granted Fast Track designation by U.S. regulators for the potential treatment of relapsed or refractory acute myeloid leukemia.
The Fast Track designation process was developed by the FDA to facilitate the development and expedite the review of new therapies that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. It allows for the possibility of a "rolling submission," or submission of individual sections as they become available, for a marketing application and provides eligibility for a priority (six month) review period by the FDA.
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