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Avastin faces setback
July 23, 2010
This week has brought some discouraging news; the FDA's advisory panel in oncology has voted against the use of the drug Avastin to treat metastatic breast cancer, and wants the label to advise against use in this population. This latest decision comes after two Phase III clinical trials that showed Avastin and chemotherapy together was not statistically significant in giving patients with metastatic breast cancer any benefit. Taking into account side effects, the risks outweighed any benefits. The final decision is to be made September 17.
Avastin is a drug called a monoclonal antibody that acts on a growth factor. This growth factor is involved in angiogenesis, which feeds tumors by directing blood flow to it. Right now, the drug is also approved for metastatic colorectal cancer, non-small cell lung cancer, renal cell carcinoma and glioma. There are studies in progress that have been showing small benefits with ovarian cancer as well.
Avastin received accelerated approval for metastatic HER2-negative breast cancer back in 2008. Although the drug has provided minor benefits in progression-free survival, which means the cancer progresses more slowly, it has not shown any benefit at all in overall survival. In fact, the improvements in progression-free survival were less than one month to under three months. When examining this in light of the drugs' staggering costs – the wholesale price for a typical breast cancer patient would be $88,000, says the NY Times – who exactly benefits here?
This ties in to what I wrote about a few weeks ago….are we prolonging survival but not improving quality of living? What is the trade-off? And who profits? Yes, this is a disappointment to many people, and questions the whole "accelerated approval" process – in fact, Breast Cancer Action urged the FDA not to approve it back in 2008. I don't have any answers, but it's certainly something to think about.
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