Xyotax gender-specific lung cancer trial
This article was originally published in Pharmaceutical Approvals Monthly
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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Device Week, 05 March - Remote Monitoring Reimbursement, T-cell Diagnostics And A Digital Health Feature
In this week's podcast, managing editor Marion Webb discusses a new monthly digital health roundup which will soon feature on Medtech Insight. Managing editor Reed Miller discusses reimbursement difficulties as it applies to remote cardiac monitoring. UK-based reporter Barnaby Pickering gives an overview of an interview with the chief medical officer of Adaptive Biotechnologies about its new T-Detect platform.