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news.Cell Therapeutics is to seek registration and approval for Xyotax, its drug to treat non-small cell lung cancer, in the US and Europe. In contrast to a more general application in Europe, the submission in the US will be in an indication to treat woman with the disease.
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“While having missed the primary endpoints will make for a challenging review with the agencies, we are committed to conducting a study to try to confirm the survival advantage seen in women who received Xyotax and plan to initiate such a clinical study in the fourth quarter of 2005,” commented Dr Jack Singer, chief medical officer of CTI. “This would be the first submission exclusively targeting survival in women with lung cancer.”
According to the American Cancer Society, lung cancer is the leading cause of cancer death among both men and women and results in more deaths per year than colorectal, breast, prostate, liver, and kidney cancers combined.
Nearly 60% of people with lung cancer die within one year of their diagnosis and nearly 75% die within 2 years; figures which have not improved in 10 years. Lung cancer is expected to kill nearly twice as many women as breast cancer this year.