Researchers in February 2006 abruptly halted recruitment of patients for a study combining the anti-cancer drugs Avastin and Xelox after several patients involved in the clinical testing died.
The maker of the drugs, Genentech and majority owner Roche Holding AG, had been testing Avastin, a prescription medication approved for use in the United States in 2004, with other drugs for the treatment of post-surgical colon cancer.
Seven deaths – four of them sudden deaths and three of those among younger patients – were noted in the phase of the study testing Avastin with Xelox, which contains Xeloda, a medication used alone since 1998 as a first-line defense in the treatment of colon cancer.
If you or a loved suffered a severe injury or death after using Avastin or Xeloda, you may want to contact a drug injury lawyer for a free evaluation of your case.
Avastin is already used for treatment of previously untreated metastatic colerectal cancer in combination with chemotherapy. Sales of the medication reached $1.1 billion in 2005 but analysts believe that Avastin, which is also being considered for the treatment of breast and lung cancer, may reach $7 billion by 2009. The latest studies sought to determine the effect of Avastin, which works by cutting the blood supply to tumors, in combination with other drugs for effectiveness in preventing the recurrence of colon cancer in post-surgical patients.
About two-thirds of the 3,450 patients needed for the study had been enrolled when Roche curtailed recruiting because of the deaths noted in one arm of the study. Patients in the group using Avastin with Xelox had roughly double the death rate of those in a group using Avastin with Folfox, another anti-cancer drug. Additionally, the U.S. Food and Drug Administration on Sept. 26, 2006 announced a new label change for Avastin noting it was linked with rare cases of a reversible posterior leukoencephalopathy, a leakage of blood from brain capillaries than can cause headaches, altered mental function and seizures. Also added to the "adverse events" portion of the label was a warning that there had been reports of nasal septum perforation associated with the use of Avastin.
Colorectal cancer is one of the leading causes of cancer, accounting for 13 percent of all cancers. Colorectal cancer kills nearly 400,000 people worldwide each year.
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