Cell Thera's Xyotax fast tracked by US FDA
The USA's Cell Therapeutics says that the Food and Drug Administration has confirmed that Xyotax, its novel biologically-enhanced version of Bristol-Myers Squibbs' popular anticancer drug, Taxol (paclitaxel), qualifies for fast-track designation for the treatment of poor performance status women with first-line advanced non-small cell lung cancer. Xyotax is currently being studied in the PIONEER clinical trial.
The firm expects completion the 600 patient enrollment target for the PIONEER trial to take about 12-14 months, noting that the product is a New Chemical Entity that links paclitaxel to a biodegradable polyglutamate polymer.
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