Novartis Signs Xyotax Development Deal With Cell Therapeutics
This article was originally published in Pharmaceutical Approvals Monthly
Novartis has signed a licensing agreement with Cell Therapeutics that could potentially hasten to market the first gender-specific therapy for the treatment of non-small cell lung cancer
You may also be interested in...
Cell Therapeutics will submit a new Xyotax (paclitaxel poliglumex) trial protocol to FDA by the end of the month after closing its Phase III PIONEER gender-specific lung cancer trial
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)...
Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011