Cell Therapeutics to file NDA for lung cancer therapy

Seattle-based Cell Therapeutics says it will push ahead with a marketing application for its experimental lung cancer therapy Xyotax in both the US and Europe. Cell Therapeutics says it will file an NDA with federal regulators seeking approval to use Xyotax for women with non-small cell lung cancer with "poor performance standards." The application is being submitted despite Xyotax's failure to hit its primary endpoint in extending the survival of patients compared to patients on existing therapies. Cell Therapeutics says it will mount a new study in the fourth quarter that it believes will demonstrate increased survival rates.

"We believe that the survival data demonstrated among women in the STELLAR 3 and 4 trials are important enough to warrant review and consideration for approval. Based on our discussions with FDA, accelerated review and non-inferiority are not possible routes to pursue in the United States. We believe that a standard review based on the gender specific survival advantage observed in women in the STELLAR 3 and 4 trials is the most appropriate registration strategy in the US," stated Jack W. Singer, MD, chief medical officer of CTI.

- read this press release for more

PLUS: The move on Xyotax comes soon after a group of dissident board members failed to oust CEO James Bianco. Four board members resigned after the failed uprising. Story