Cell Therapeutics Cancer Drug Gains Fast Track Status
Posted on: Wednesday, 11 April 2007, 12:00 CDT
Cell Therapeutics has reported that Xyotax, a biologically-enhanced version of the cancer drug, Taxol, has qualified for fast track designation for the treatment of PS2 or poor performance status women with first-line advanced non-small cell lung cancer.
The company recently filed a special protocol assessment with the FDA for the design of its phase III trial of Xyotax for women with advanced non-small cell lung cancer (NSCLC). The trial will focus exclusively on women with normal estrogen levels, the subset where Xyotax demonstrated the greatest survival advantage in previous trials.
Fast track designation was granted because NSCLC in PS2 patients is incurable with available therapy offering only modest benefit, and Xyotax has the potential to demonstrate improvement over available therapy in these patients.
"Pending FDA feedback, we anticipate that one or both of these trials would begin enrollment in the second quarter of 2007 with a targeted interim analysis in the first half of 2008," said James Bianco, president and CEO of CTI.
Fast track designation means the FDA will facilitate and expedite the development and review of the application for the approval of a new drug intended for the treatment of a serious or life-threatening condition. An expedited review as defined by the FDA user fee performance goals provides for a review within six months.
Source: Datamonitor
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