November 18th, 2011
02:03 PM ET
The Food and Drug Administration announced Friday that it was revoking its approval of the drug Avastin for metastatic breast cancer after concluding that it has not been shown to be safe and effective for that use.
"The FDA 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," said FDA Commissioner Margaret Hamburg, who made the announcement.
“As a doctor, a woman and a parent, I know how frightening a diagnosis of metastatic breast cancer can be and the need for good treatment, but after reviewing the available studies," she said, there is no evidence that Avastin does "help women with metastatic breast cancer live longer or improve their quality of life."
The FDA’s decision removes the use of Avastin in combination with the cancer drug paclitaxel for women who had not been treated with chemotherapy for the form of metastatic breast cancer known as HER2 negative. The removal is based on extensive records, which include thousands of pages submitted to a public docket, data from several clinical trials and the record from a two-day hearing in June 2011, as well testimony from a hearing on the drug held in December of last year.
Avastin went through an accelerated approval process so it could go to women who needed treatment. After the approval, the drug's sponsor, Genentech, completed two additional clinical trials and submitted the data from those studies to the FDA. The data showed only a small effect on tumor growth without showing that patients lived any longer or had a better quality of life, compared with taking standard chemotherapy.
“We found after rigorous testing the side effects of Avastin were more damaging than the benefits,” Hamburg said.
Tests showed that side effects from the drug included bleeding, hemorrhaging, chance of heart failure or heart attack and high blood pressure, as well as perforation of the body, including the stomach, nose and intestines.
Although the drug has been deemed “unsafe,” many women on Avastin swear by it and say it has made a difference in their lives. Although Avastin will still be available once the FDA removes the approval, it will no longer be covered by insurance for use against breast cancer, and that’s a main concern with patients.
“The FDA doesn’t regulate the practice of medicine,” Hamburg said. “It is up to a patient and doctor to discuss the risks and benefits."
In a written response, Genentech said, “We are disappointed with this outcome. We remain committed to the many women with this incurable disease and will continue to provide help through our patient support programs to those who may be facing obstacles to receiving their treatment.”
The statement continued, “Despite today’s action, we will start a new Phase III study of Avastin in combination with paclitaxel in previously untreated metastatic breast cancer and will evaluate a potential biomarker that may help identify which people might derive a more substantial benefit from Avastin.”
When asked if the FDA would reconsider Avastin for metastatic breast cancer if more tests from Genentech found it to be safe and effective, Hamburg was open to discussion.
“We will work with Genentech on this issue,” she said. “But for now, this is our decision.”
Avastin will still remain on the market as an approved treatment for certain types of colon, lung, kidney and brain cancers.
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