San Francisco — Sunesis Pharmaceuticals announced that vosaroxin, the company’s lead drug candidate, has been granted Fast Track
designation by the FDA for the potential treatment of relapsed or refractory acute myeloid leukemia (AML) in combination with cytarabine.
The Fast Track designation is a process 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 United States. The designation provides eligibility for a 7-year period of market exclusivity in the United States 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 amultinational, 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 United States, 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, CEO 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."
VALOR is a Phase 3, randomized, double-blind, placebo-controlled, pivotal trial in patients with first relapsed or refractory AML. The trial is expected to enroll 450 evaluable patients at leading sites in the U.S., Canada, Europe, Australia and New Zealand. VALOR is currently open for enrollment and patients will be randomized one-to-one to receive either vosaroxin on days one and four in combination with cytarabine daily for 5 days, or placebo in combination with cytarabine. Additionally, the VALOR trial employs an innovative,
adaptive trial design that allows for a one-time sample size adjustment by the DSMB at the interim analysis to maintain adequate power across a broad range of clinically meaningful and statistically significant survival outcomes. The trial’s primary endpoint is overall survival.
SOURCE: Sunesis Pharmaceuticals