NaturalNews) An FDA advisory panel has said that the drug Avastin should not be used to treat breast cancer, because it fails to provide enough benefit to outweigh the risks.
Avastin, known generically as bevacizumab, has been approved for the treatment of colon and lung cancer. It is a major seller for producer Genentech, generating $1.7 billion for the company in the first nine months of 2007.
An FDA review of the drug concluded that while Avastin appeared to lengthen the amount of time before a cancer became severe, it did not significantly lengthen the lives of patients. In addition, some patients taking the drugs experienced serious side effects, which may have led to death in five cases.
In a clinical trial sponsored by the National Cancer Institute, researchers gave breast cancer patients either a combination of Avastin and the breast cancer drug paclitaxel (also marketed as Taxol) or just paclitaxel alone. They found that the drug combination nearly doubled the time before breast tumors worsened, from 5.8 months with paclitaxel alone to 11.3 months with the combination. Preliminary results of the study were released in April 2005, before the end of the study.
But a complete analysis of the final data showed that there was no significant difference between how long patients lived whether they received both drugs or paclitaxel alone.
In addition, while there were no treatment-related deaths in the group receiving only paclitaxel alone, there were five in the other group. One of these was a 64-year-old woman who died due to a serious infection and a bowel perforation, a known side effect of Avastin
. The overall serious side effect rate in the paclitaxel-only group was 51 percent, compared with 71 percent in the dual-drug group.
According to Genentech, paclitaxel treatment is normally stopped when tumors worsen. Because Avastin apparently lengthened the time before this happened, this may have unintentionally led to paclitaxel's toxic effects building up in the body, leading to the higher rate of side effects.
Avastin is also known to have cardiovascular side effects.
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