An expert panel at the Food and Drug Administration on Tuesday recommended that the top-selling cancer drug Avastin not be used to treat breast cancer, saying the drug does not significantly benefit patients with the disease.
If the FDA acts on the recommendation, drug maker Roche Holding AG would no longer be able to market the drug for breast cancer, though doctors could still prescribe it for that use. Avastin is also approved for treating brain, lung, colon and kidney cancer, the Los Angeles Times reports.
Avastin entered the market in 2008 through an accelerated approval process, which required Roche to conduct two post-market clinical trials to assess the drug’s effectiveness. Because the studies failed to prove that the drug significantly extends life for breast cancer patients, the advisory panel voted 12-1 to end Avastin’s use for the disease.
In a statement, Roche subsidiary Genentech, which manufactures Avastin, said it believed the drug “should continue to be an option” for patients with breast cancer.
Avastin is a best-selling cancer drug with sales of $6 billion a year.
The FDA generally follows expert panel recommendations, although it is not bound by them. The agency is expected to make a decision by Sept. 17.


