The commissioner of the Food and Drug Administration on Friday revoked the approval of the drug Avastin as a treatment for breast cancer, ruling on an emotional issue that pitted the hopes of some desperate patients against the statistics of clinical trials.
The commissioner, Dr. Margaret A. Hamburg, said that clinical trials had shown that the drug was not helping breast cancer patients to live longer or to meaningfully control their tumors, but did expose them to potentially serious side effects like severe high blood pressure and hemorrhaging.
“Sometimes, despite the hopes of investigators, patients, industry and even the F.D.A. itself, the results of rigorous testing can be disappointing,” Dr. Hamburg told reporters Friday. “This is the case with Avastin when used for the treatment of metastatic breast cancer.”
Avastin will remain on the market as a treatment for other types of cancers, so doctors can use it off-label for breast cancer. But insurers might no longer pay for the drug, which would put it out of reach of many women because it costs about $88,000 a year.
Federal officials said on Friday that Medicare would still provide coverage for the drug’s use in breast cancer, though the government plans to “monitor the issue and evaluate coverage options.”
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Or the manufacturer can reduce the cost to what it would be if was available generically (which in a free market system would be the result of decreased demand).