Avastin to be recalled from the market

Raluca Coman

Written by Raluca Coman on July 22nd 2010
Posted in: Featured, Health, U.S. News
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An advisory panel of the United States Food and Drug Administration has voted 12 to 1 for not approving the cancer drug Avastin for the treatment of advanced breast cancer.
The decision is the result of two clinical trials that could not demonstrate the benefit of the drug compared to its serious side effects. It has been found out that Avastin added to standard chemotherapy does not keep cancer from advancing at a meaningful rate and the panel decided that the Food and Drug Administration should recall approval for Avastin to be sold on the market. If the advice of the panel is taken into consideration Avastin would still be approved only for the treatment of lung, kidney, and colon cancer.

The FDA approved faster that usual Avastin to be sold to patients with metastatic breast cancer because in combination with chemotherapy it had been proved to have positive effects, learned from a study sponsored by the production company. But the two later clinical trials performed on 2,000 breast cancer patients proved that the situation was not as they believed. The panel voted unanimously that that the two trials did not demonstrate anough benefits compared to the drugs’ risks, including a small risk of death, bleeding and hypertension. the results of the clinical trials also suggested that patients taking the drug did not survive longer than the ones who did not take it.11


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2013-06-20 09:11:12