Drug Development
Marketing applications to be submitted for Xyotax in U.S, Europe
Published in Cancer Weekly, September 20th, 2005
In the United States, CTI plans to submit a New Drug Application (NDA) and seek approval for Xyotax as first-line monotherapy for women with advanced non-small cell lung cancer (NSCLC) who have poor performance status (PS2).
The filing in Europe will also seek use as monotherapy in first-line PS2 patients with NSCLC, but is not expected to be limited to women; however, additional input on the statistical interpretation of non-inferiority will be needed from the scientific committee of the European Medicines Agency...
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Source: Cancer Weekly (2005-09-20)
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