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news.Cell Therapeutics has submitted a marketing authorization application or MAA to the European Medicines Agency for Xyotax for first-line treatment of patients with non-small cell lung cancer who have ECOG or Eastern Cooperative Oncology Group performance status 2.
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The application is based on a positive opinion from the agency’s Scientific Advice Working Party, which agreed to review the application based on the existing results of the Phase III clinical trials of Xyotax. The application will be formally reviewed for validation by the end of March, 2008. Upon validation, the marketing approval review process begins, which generally takes 15 to 18 months.
James Bianco, president and CEO of Cell Therapeutics, said: “This is an important milestone for the company and demonstrates our commitment to bring Xyotax to this underserved group of patients. Every day counts when treating patients who may have an average life expectancy of only six months, so quality of life and less time in the doctor’s office or hospital are important benefits for these patients.”