The US Food and Drug Administration (FDA) has granted Cell Therapeutics’ Xyotax (paclitaxel poliglumex), a novel biologically-enhanced version of the popular cancer treatment Taxol (paclitaxel), a speedy review for the treatment of women with first-line advanced non-small cell lung cancer (NSCLC).
The fast-track designation was granted because NSCLC in poor performance status (PS2) patients is incurable with current therapies, and Xyotax has shown the potential for superior efficacy in these patients, according to the company. The firm is currently enrolling patients in the PIONEER trial, the first approval trial for lung cancer exclusively targeting women.
The news sparked a frenzied bout of trading on the Nasdaq yesterday, with the effect of pushing shares up 10.3% to close $2.03, reflecting investor excitement on the development.
