FDA commissioner Margaret Hamburg said that the drug was neither helping patients live longer nor preventing tumors from metastasizing. Instead, the drug came with potentially lethal side effects like extreme blood pressure and hemorrhaging.
“This was a difficult decision,” Dr. Hamburg, said in a statement.
According to the Times:
The F.D.A. “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,” she continued, “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 help them live longer or improve their quality of life.”
While Avastin will remain on the market as treatment for other types of cancer, but some insurers will no longer pay for the drug.
Medicare, however, has said that it will continue to pay for the drug's treatment of breast cancer.
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