Sunesis Receives Fast-track Designation from FDA for Osaroxin

Sunesis Pharmaceuticals, Inc. announced the Company's lead drug candidate has been granted fast- track designation by the U.S. FDA for the potential treatment of relapsed or refractory acute myeloid leukemia in combination with cytarabine.

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.

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 t