The US Food and Drug Administration confirmed that Cell Therapeutics' Xyotax, a novel biologically-enhanced version of one of the most used cancer drugs, Taxol, qualifies for fast track designation for the treatment of PS2 (poor performance status) women with first-line advanced non-small cell lung cancer (NSCLC), which is currently being studied in the PIONEER clinical trial.
The company has initiated a number of clinical sites and is currently enrolling patients on the PIONEER trial, the first approval trial for lung cancer exclusively targeting women, claims the Cell Therapeutics release.
Fast track designation was granted because NSCLC in PS2 patients is incurable with available therapy offering only modest benefit, and xyotax has the potential to demonstrate improvement over available therapy in these patients.
Xyotax (paclitaxel poliglumex) is a biologically-enhanced chemotherapeutic that links paclitaxel, the active ingredient in Taxol, to a biodegradable polyglutamate polymer, which results in a new chemical entity.
Cell Therapeutics Inc. is a biopharmaceutical company focus on developing an integrated portfolio of oncology products aimed at making cancer more treatable.