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news.Allos Therapeutics, a biopharmaceutical company, has submitted a new drug application to the FDA for the use of pralatrexate for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma.
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The company has requested a priority review of the application, which, if granted, would give the FDA six months from receipt of the submission to take action on the application.
The new drug application (NDA) is based on the results from the company’s pivotal Phase II trial known as Propel. The Propel trial was conducted under an agreement reached with the FDA under its special protocol assessment process.
Paul Berns, president and CEO of Allos, said: “We plan to work closely with the FDA to facilitate the completion of their review as expeditiously as possible. If approved, pralatrexate represents a potential first-to-market opportunity for Allos and could be the first agent approved by the FDA for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma.”