FDA Grants Fast-Track Designation for Phenoxodiol in Oral Dosage Form

The FDA has granted Marshall Edwards' investigational anticancer drug, phenoxodiol, fast-track status for its intended use in patients with hormone-refractory prostate cancer (HRPC).

The successful application for fast-track status was based on data derived in a Phase Ib/IIa study, conducted in two Australian hospitals, in which men with late stage HRPC were treated with the oral dosage form of phenoxodiol as a monotherapy.