FDA revokes Avastin as breast cancer treatment


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Avastin should no longer be used for treating breast cancer, the Food and Drug Administration announced on Friday, saying that the drug has not been shown to be safe or effective for such use.

In a prepared statement, FDA Commissioner Margaret A. Hamburg announced the decision to revoke her agency’s approval of the drug for breast cancer treatment. The ruling had been expected but will likely disappoint patients who have few options in treatment.


“This was a difficult decision,” Hamburg said in her statement. “FDA recognizes how hard it is for patients and their families to cope with metastatic breast cancer and how great a need there is for more effective treatments. But patients must have confidence that the drugs they take are both safe and effective for their intended use.

“After reviewing the available studies it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth, that would justify those risks. Nor is there evidence that use of Avastin will either help them live longer or improve their quality of life,” she said.

According to the FDA, the possible side effects include severe high blood pressure; bleeding and hemorrhaging; heart attack or heart failure; and the development of perforations in different parts of the body such as the nose, stomach, and intestines.

Avastin will continue to be legal for use as a treatment for other illnesses, including types of colon, lung, kidney and brain cancers. Some doctors may continue to prescribe it for breast cancer as well, a practice known as off-label use. However, the FDA action could have an impact on whether insurance companies will continue to pay for the drug for breast cancer.

The FDA decision could hurt sales of the drug, manufactured by Genentech, which was bought by the Swiss company Roche in 2009.

In a statement emailed to reporters, Genentech said it was disappointed by the FDA decision.

“We are disappointed with this outcome. We remain committed to the many women with this incurable disease and will continue to provide help through our patient support programs to those who may be facing obstacles to receiving their treatment,” the company said.

Genentech added it will move forward with a new Phase III study of the drug “that may help identify which people might derive a more substantial benefit from Avastin.”

Avastin was approved for treating metastatic breast cancer in February 2008 under the FDA’s accelerated approval program.


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-- Michael Muskal