Xyotax Fast Tracked for Advanced NSCLC in Women

SEATTLE—Cell Therapeutics' Xyotax (paclitaxel poliglumex), a biologically enhanced chemotherapeutic that links paclitaxel to a biodegradable polyglutamate polymer, has gained fast track status from the FDA for the first-line treatment of advanced non-small-cell lung cancer (NSCLC) in women with poor performance status. A pooled analysis from three studies showed that women treated with Xyotax plus carboplatin had a 39% probability of living at least 1 year, compared with 25% for men. Clinical studies support that metabolism of Xyotax may be influenced by estrogen, thus leading to enhanced efficacy in women with lung cancer. The phase III PIONEER trial is evaluating Xyotax in this setting in women at 170 sites.