Pharmion’s Oral Azacitidine Granted Fast-Track Status

Pharmion announced that the FDA has granted fast-track designation for oral Azacitidine in the treatment of myelodysplastic syndromes.

Pharmion currently markets the parenteral formulation of azacitidine, known as Vidaza (azacitidine for injection) for the treatment of patients with myelodysplastic syndromes.

The company oral Azacitidine is the subject of a Phase I multicenter, open-label, dose-escalation trial that will assess the maximum tolerated dose, dose-limiting toxicities and safety of a seven day, multicycle oral dosing regimen of oral Azacitidine in patients with myelodysplastic syndromes and acute myeloid leukemia.