Digital News Report – The U.S. Food and Drug Administration (FDA) released a statement Friday indicating that Avastin (bevacizumab) has not been shown to be safe and “effective” against breast cancer.
The drug is still approved and remains on the market for colon, lung, kidney and brain cancer. Avastin was first approved in 2004 to work in conjunction with other chemotherapies against colon cancer.
In 2008 Avastin was approved for metastic breast cancer, however there was a controversy. There was no evidence that it extended life or improved the quality of life. It also caused adverse side effects including severe hypertension and hemorrhaging.
After further studies an FDA panel advised against recommending the drug for breast cancer, even advanced breast cancer. The maker of the drug, Genentech, was granted a hearing in June and the FDA finally ruled on the matter this month, withdrawing Avastin from their approved list of treatments for breast cancer.
“This was a difficult decision. 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,” said FDA Commissioner Margaret A. Hamburg, M.D. said in her statement.
It was a tough decision. At the June hearings patients opposed to removing the drug from the approved list spoke out in favor of keeping the option open. Priscilla Howard, a metastic breast cancer patient, is quoted as saying she wanted every weapon at her disposal.
“I encourage Genentech to consider additional studies to identify if there are select subgroups of women suffering from breast cancer who might benefit from this drug,” Dr. Hamburg said.
By: Jason Chang