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Fast Track Review for Allos

The FDA designation is for the lymphoma drug PDX.

Allos Therapeutics


jumped after the company said the Food and Drug Administration granted its lymphoma drug PDX fast track review status.

The stock was up 4.6% to $3.91 Tuesday.

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The designation, which is given for new drugs intended to treat serious or life-threatening illnesses, allows companies to submit applications for marketing approval as data becomes available instead of all at once. The designation could also result in a priority review of the application, the company says.

PDX is currently in mid-stage trials. Allos is seeking to enroll 100 patients with a blood cancer known as relapsed or refractory peripheral T-cell lymphoma. The main goal of the trial is to determine the rate of tumor reduction and elimination.

In July, the FDA gave PDX orphan drug designation, a status that allows the company certain benefits such as assistance and advice on how clinical trials should be conducted, as well as a period of marketing exclusivity and tax benefits.