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Review of Lung Cancer Drug to get Fast Track at FDA

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Review of cancer drug to get fast track at FDA

Cell Therapeutics Inc. said yesterday that its lung-cancer treatment will get a faster review from the Food and Drug Administration because it addresses an unmet medical need.

The company's Xyotax medicine for advanced, non-small-cell lung cancer is in the final stage of two clinical trials, and Cell Therapeutics may file for the drug's approval by the end of 2004, it said in a statement. This type of lung cancer is incurable and current treatments have only a modest benefit, the company said.

Fast-track designation means the agency will speed review of an application for a treatment of a life-threatening condition that has demonstrated the potential to address an unmet need. Xyotax contains paclitaxel, the main ingredient in Bristol-Myers Squibb Co.'s Taxol cancer treatment.

http://seattlepi.nwsource.com/business/ ... brf17.html

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