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Safety concerns halt Avastin trial
Genentech and Roche Holdings, its majority owner, have suspended enrollment in a Phase III trial of Avastin for colon cancer after the deaths of four patients. Three of those four patients were younger people taking Avastin with Xeloda, which particularly troubled researchers. The news immediately hit shares of Roche in early trading. Researchers are exploring the utility of Avastin as an adjuvant therapy for post-surgical colon cancer. The Data Safety Monitoring Board believes that the rapid enrollment of 200 patients a month may have hindered proper safety evaluations.
Genentech said that it was right to temporarily halt enrollment so they could do a thorough analysis of safety data. Avastin is approved for colorectal cancer in patients whose disease has metastasized, an indication that should earn the companies $1.5 billion this year. Analysts doubted that the trial setback would create any significant long-term damage for either company's earnings.
- read this article from the Financial Times


