Xyotax granted fast track status by FDA

Cell Therapeutics has received fast track designation from the FDA for Xyotax (CT-2103), its polyglutamate paclitaxel, for the treatment of advanced non-small cell lung cancer (NSCLC) in patients with a poor performance status (PS2).

Fast track designation was granted because NSCLC in PS2 patients is incurable with available therapy offering only modest benefit, and Xyotax has the potential to demonstrate improvement over available therapy in these patients based on anticancer activity (tumour shrinkage) in phase I and II clinical trials.

'We are extremely pleased that the FDA recognises that this population of patients has few viable treatment alternatives and that Xyotax has the potential to offer improvement over existing therapies,' stated James A. Bianco, president and ceo of CTI. 'Fast track designation of Xyotax represents a major regulatory milestone in the development of this product candidate.'

Xyotax is currently in two phase III clinical trials for PS2 patients with advanced NSCLC. A new drug application for this indication is targeted for the end of 2004. Xyotax is also being studied in a phase III clinical trial among patients with non-small cell lung cancer who have relapsed following a single platinum-containing front-line treatment.

According to the American Cancer Society, approximately 172,000 new cases of lung cancer are expected during 2003. Non-small cell lung cancer accounts for almost 80% of lung cancer cases and PS2 patients make up roughly 20 to 30% of the newly diagnosed advanced NSCLC patients.