Allos Therapeutics, Inc announced that the US 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. "Over the next several months, we will continue to work closely with the FDA to support their review of the NDA. If approved, pralatrexate would be the first agent approved by the FDA for the treatment of patients with relapsed or refractory PTCL and represents a potential first-to-market opportunity for Allos."

The NDA is based on the results from the company's pivotal phase-2 trial known as PROPEL (Pralatrexate in patients with Relapsed Or refractory PEripheral T-cell Lymphoma). The PROPEL trial was conducted under an agreement reached with the FDA under its Special Protocol Assessment, or SPA, process. Pralatrexate has orphan drug designation and fast track designation in the US for the treatment of patients with T-cell lymphoma and orphan medicinal product designation in Europe for the treatment of PTCL. The company believes the PROPEL trial is the largest prospectively designed single-agent trial conducted to date in patients with relapsed or refractory PTCL. The company retains exclusive worldwide rights to pralatrexate for all indications.

Pralatrexate is a targeted antifolate designed to accumulate preferentially in cancer cells.

Allos Therapeutics is a biopharmaceutical company focused on developing and commercializing innovative small molecule drugs for the treatment of cancer.