Cell Therapeutics announces Xyotax regulatory plans

CTIC said it will pursue different strategies for regulatory submissions to FDA and EMEA for Xyotax paclitaxel poliglumex. The company plans to submit an NDA to FDA in the first half of next year for Xyotax as first-line monotherapy for women with advanced non-small cell lung cancer (NSCLC) who have poor performance status (PS2). CTIC plans to submit an MAA to EMEA later in 2006 that will seek use as monotherapy in male and female first-line PS2 patients with NSCLC. ...