Allos Therapeutics, Inc. (ALTH) said that the U.S. Food and Drug Administration has accepted for filing the company's New Drug Application, or NDA, for pralatrexate for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma.
The company also announced that the FDA has granted the NDA priority review status and established a Prescription Drug User Fee Act date of September 24, 2009 for a decision regarding approval of the NDA.
The company noted that the NDA is based on the results from its pivotal Phase 2 trial known as PROPEL.
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