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US FDA to review Allos Therapeutics' pralatrexate NDA
Westminster, Colorado | Thursday, August 13, 2009, 08:00 Hrs  [IST]

Allos Therapeutics, Inc has received notification from the US Food and Drug Administration (FDA) that the Oncologic Drugs Advisory Committee (ODAC) will hold a meeting on September 2, 2009, to review 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 submitted the NDA in March 2009. In May 2009, the FDA accepted the NDA for priority review and established a Prescription Drug User Fee Act date of September 24, 2009 for a decision regarding approval of the NDA.

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

Allos Therapeutics is a biopharmaceutical company committed to the development and commercialization of innovative anti-cancer therapeutics.

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