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Xyotax Fails To Show Survival Benefit Again; CTI Continues To Tout Safety Profile

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

CTI’s repeated STELLAR trial failures to show Xyotax survival benefit for lung cancer could delay NDA submission. Detailed STELLAR 2 and 4 data showing equivalent survival with significant reductions in side effects compared to docetaxel or gemcitabine/vinorelbine will be presented in July

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CTI To Pursue Xyotax Lung Cancer Indication Limited To Women

Cell Therapeutics will focus its submission for FDA approval of Xyotax as a first-line treatment for advanced non-small cell lung cancer in women only

Xyotax STELLAR trial update

Cell Therapeutics' Xyotax (paclitaxel poliglumex) showed a statistically significant, 40% improvement in survival compared to vinorelbine for first-line treatment of poor performance status (PS2) non-small cell lung cancer in the firm's STELLAR 4 trial (n=32, p=0.012, hazard ratio 0.6), the firm says. On-study deaths also were significantly reduced compared to vinorelbine or gemcitabine. CTI previously reported that the 381-patient trial showed a non-significant increase in median survival compared to controls receiving either gemcitabine or vinorelbine (1Pharmaceutical Approvals Monthly May 2005, p. 4)...

STELLAR Failure For Xyotax Leads CTI To Focus On Non-Inferiority






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