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FDA revokes approval of Avastin for breast cancer treatment

by Kelly MacNeil on December 17, 2010

After recent studies showed less promise in slowing breast cancer than originally thought, the Food and Drug administration advised doctors on Thursday not to use the drug Avastin as a treatment for the disease any longer. The decision sparked an outcry from patients and doctors who claim that the drug is a viable option, The Associated Press reports.

While some healthcare professionals claim that the drug is effective, many cancer experts disagree. The decision is expected to cost the drug's manufacturer, Roche, hundreds of millions of dollars in lost revenue and the company has indicated that it will fight the decision until after a public hearing on the issue. The move is interesting as many companies usually comply with FDA recommendations.

The drug was approved two years ago after initial studies showed that it was effective at stopping the spread of cancer in conjunction with chemotherapy. However, further studies showed that the results were not as encouraging and patients ran the risk of developing side effects.

"Given the number of serious and life-threatening side effects, the FDA does not believe there is a favorable risk-to-benefit ratio," Dr. Richard Pazdur, FDA's chief of cancer drug review, told the news source.

Still, around 9,500 individuals signed a petition to keep the drug available, citing the fact that it has improved numerous conditions. Dr. Julie Gralow, a Seattle-based physician, said that a certain subset of patients find it especially beneficial.

Officials in Europe broke from the FDA and kept the drug available, a move which is due to a difference in the approval process, experts say. Although it's use for breast cancer has been revoked, the drug is still used to treat different types of colon, lung, kidney and brain cancer.

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