Cell Therapeutics' ( CTIC) lung-cancer candidate received fast-track status from the Food and Drug Administration, and the company's shares rallied as a result.

In early trading, the shares were up $1.81, or 13%, to $14.83.

The drug, Xyotax, is currently in two phase II trials for advanced non-small cell lung cancer in patients with so-called "poor performance status." Fast-track status was granted because the disease, once it reaches the advanced stage, is incurable with available therapies, and "Xyotax has the potential to demonstrate improvement," the company said.

Under fast-track, the FDA will expedite the development and review of approval application if the drug is intended for a serious or life-threatening condition and demonstrates the potential to address an unmet medical need. An expedited review as defined by the FDA user fee performance goals provides for a review within six months.

About 172,000 new cases of lung cancer are expected in 2003, with non-small cell accounting for about 80%.