The agency announced on Friday that there's no proof that the world's best-selling cancer drug extends the lives of patients with advanced breast cancer or even provides enough benefits to outweigh the risks.
The FDA said those risks can include severe high blood pressure, massive bleeding or heart failure.
"I did not come to this decision lightly," said the FDA commissioner, Dr. Margaret Hamburg. But, she said, "Sometimes despite the hopes of investigators, patients, industry and even the FDA itself, the results of rigorous testing can be disappointing."
Avastin will continue to remain an approved treatment for certain types of colon, lung, kidney and brain cancers.
The ruling was long expected, but it was certain to disappoint women who say they've run out of other options. Impassioned patients had lobbied furiously to preserve Avastin.
Repeated studies found the drug had only a small effect on tumor growth. The research didn't show evidence that patients lived any longer or had a better quality of life than if they had taken standard chemotherapy.
Doctors can still prescribe Avastin, but insurers may not pay for it. Including infusion fees, a year's treatment with Avastin can cost $100,000.
Some insurers, including Blue Shield of California, had already quit covering the drug's use in breast cancer after FDA's advisers twice urged revoking the approval, but Medicare said Friday that it will keep paying for now. In a statement, the agency said it "will monitor the issue and evaluate coverage options as a result of action by the FDA but has no immediate plans to change coverage policies."
The Associated Press contributed to this report.