The FDA today recommended to remove the breast-cancer indication from the label of Avastin (bevacizumab) after reviewing the results of four clinical studies (www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm237172.htm).
Today’s action will have no immediate impact on the use of the drug, which will remain on the market. Avastin’s approvals for the treatment of colon, kidney, brain, and lung cancers remain intact. The FDA is advising providers who are now using Avastin in patients with metastatic breast cancer to use their medical judgment as to whether to continue treatment or consider other therapeutic options.
According to the agency, Avastin has not been shown to be safe and effective for use in breast cancer. In the studies reviewed, the medication did not prolong overall survival in women with metastatic disease, nor did it provide a benefit in slowing disease progression sufficient to outweigh the significant risk, including severe high blood pressure; bleeding and hemorrhage; the development of perforations in the nose, stomach, intestines, or other parts of the body; and heart attack or heart failure.
The FDA recommendation follows a July 2010 vote by an independent advisory committee to remove the breast-cancer indication from Avastin’s label. The members of that committee—primarily oncologists—voted 12-1 in favor of removal.
The FDA notes that this is only the first step in the process of removing the breast-cancer indication from Avastin. Genentech, which manufactures the agent, has 15 days to request a public hearing to contest the FDA’s decision. The company, in turn, has announced that it intends to do so.
“Until the conclusion of these proceedings, Avastin remains FDA-approved for use in combination with paclitaxel for the first-line treatment of metastatic HER2-negative breast cancer,” affirmed Genentech in a press release today (www.gene.com/gene/news/press-releases/display.do?method=detail&id=13127).
In that statement, the company also cited reviews from the European Medicines Agency that contradict the FDA’s stance. According to Genentech:
–The EMA has confirmed that Avastin in combination with paclitaxel has been convincingly shown to enable women with metastatic breast cancer to live longer without their disease getting worse (progression-free survival).
–The EMA has also stated that “the benefits of this combination outweigh its risks and that this combination remains a valuable treatment option for patients suffering from metastatic breast cancer.”