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Xyotax gender-specific lung cancer trial

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA has granted Cell Therapeutics' polymer-linked paclitaxel Xyotax (paclitaxel poliglumex) fast track status for first-line treatment of poor performance status (PS2) women with advanced non-small cell lung cancer (NSCLC), the firm announces Feb. 8. The firm expects its PIONEER trial to enroll 600 women over the next 12 to 14 months; PIONEER is "the first approval trial for lung cancer exclusively targeting women," CTI states. CTI has experienced several setbacks in developing Xyotax in NSCLC, with its STELLAR trials failing to show a survival benefit in the general NSCLC population. The firm subsequently shifted its focus to women only (1Pharmaceutical Approvals Monthly September 2005, p. 16)...

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