FDA grants Fast Track designation to Sunesis' vosaroxin for treatment of AML

Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSSD) today announced that vosaroxin, the Company's lead drug candidate, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the potential treatment of relapsed or refractory acute myeloid leukemia (AML) in combination with cytarabine.

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. Specifically, Fast Track designation 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.

Vosaroxin was granted orphan drug designation by the FDA for the treatment of AML in 2009. Orphan drug designation is granted by the FDA Office of Orphan Drug Products to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designation provides eligibility for a seven-year period of market exclusivity in the U.S. after product approval and an exemption from user fees.

Patients with first relapsed or refractory AML are currently enrolling in a Phase 3 trial of vosaroxin, known as VALOR. The VALOR trial is a multinational, randomized, double-blind, placebo-controlled, pivotal trial of vosaroxin in combination with cytarabine, which is expected to enroll 450 evaluable patients at leading sites in the U.S., Canada, Europe, Australia and New Zealand.

"Vosaroxin's Fast Track designation, along with its orphan drug designation, highlights the urgent need for new therapeutic options for patients with first relapsed or refractory AML," stated Daniel Swisher, Chief Executive Officer of Sunesis. "We are encouraged by the initial roll out of the VALOR trial and are highly focused on its successful prosecution. We look forward to opening new sites around the world and rapidly and efficiently accruing patients into VALOR."

Source: Sunesis Pharmaceuticals, Inc