Approval of the drug, Avastin, used to treat breast cancer, has been revoked by the Food and Drug Administration as of November 18, 2011. They say that the drug was not helping breast cancer patients live longer or control their tumors, it was actually causing them to have more side effects than doing any good.
Dr. Margaret A. Hamburg, commissioner for the Food and Drug Administraion said, “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 help them live longer or improve their quality of life.”
This ruling might disappoint some women who had high hopes and have ran out of other options, but it’s been long expected from the Food and Drug Administration. FDA Commissioner Dr. Margaret Hamburg called the decision difficult but said patients must have confidence that drugs sold for their condition are effective.
Although, Avastin will still remain on the market for treating other types of cancers, but don’t count on your health insurance to pay for it. Some health insurance companies had already stopped covering Avastin for the treatment of breast cancer, but others were waiting for the statement from the F.D.A. However, Medicare will still continue to pay for Avastin for the use of breast cancer until they evaluate to see if a change will be needed. Even if women wanted to continue without insurance paying for it, it would cost them around $88,000 a year.
Dr. Hamburg, said in a statement, “This was a difficult decision. 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.”
In an interview with CBS news Dr. Stephanie Bernik of Lenox Hill Hospital in New York said, “I think the FDA is doing the right thing since the drug has some serious complications. However, there are definitely patients who are benefiting from the drug and if the FDA completely withdraws approval those patients may find it hard to get access.”
Watch the video below that explains more about the Avastin Drug for treating Breast Cancer and Avastin side effects:
- FDA revokes Avastin approval (cbsnews.com)
- FDA Rules Against Use of Avastin in Treatment of Breast Cancer (foxnews.com)