Sunesis Pharmaceuticals has received fast-track designation from the US Food and Drug Administration (FDA) for vosaroxin, a drug candidate for the treatment of relapsed or refractory acute myeloid leukaemia in combination with cytarabine.
The designation is granted to facilitate the development and expedite the review of new therapies that are intended to treat serious or life-threatening conditions.
Vosaroxin received orphan drug designation in 2009.
Sunesis is enrolling patients with relapsed or refractory acute myeloid leukaemia in a Phase III trial of vosaroxin in combination with cytarabine.
around 450 patients are expected to be enrolled in the multinational, randomised, double-blind, placebo-controlled trial at sites in the US, Canada, Europe, Australia and New Zealand.
In the study, patients will be randomised to receive either vosaroxin in combination with cytarabine, or placebo in combination with cytarabine.
The primary endpoint of the trial is overall survival.