Allos Therapeutics (ALTH) Announces FDA Accepts Pralatrexate NDA for Filing and Grants the Application Priority Review Status

May 26, 2009 8:16 AM EDT

Allos Therapeutics, Inc. (NASDAQ: ALTH) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for pralatrexate for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The Company also announced that the FDA has granted the NDA priority review status and established a Prescription Drug User Fee Act (PDUFA) date of September 24, 2009 for a decision regarding approval of the NDA. Priority review designation is assigned to drugs that have the potential to provide a significant improvement compared to marketed products or provide a safe and effective therapy where no satisfactory therapy exists.

"We are pleased the FDA has accepted our application for filing and granted it priority review status, a designation that emphasizes the significant need for new agents that advance the treatment of patients with relapsed or refractory peripheral T-cell lymphoma," said Paul L. Berns, president and chief executive officer of Allos Therapeutics, Inc.

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