Avastin's approval for the treatment of breast cancer has been revoked, the FDA (Food and Drug Administration) announced today. The US regulatory agency says that Avastin is neither effective nor safe for that particular type of cancer.
The FDA and Roche, the makers of Avastin (bevacizumab), emphasize that this update does not affect Avastin's current approved usage for treating other types of cancer, such as colon, kidney, brain and lung cancers..
There is no evidence that Avastin provides benefits for the treatment of breast cancer. The FDA added that the medication has a risk of heart failure, very high blood pressure, and severe bleeding (hemorrhaging).
FDA Commisioner, Dr. Margaret A. Hamburg, said:
"This was a difficult decision. . . . . (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.
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."
Four different human studies (clinical trials) had demonstrated that Avastin did not prolong overall survival, neither did it slow down disease progression enough to outweigh the medication's existing risks.
Experts say Roche may lose up to $1 billion in revenue from its blockbuster (best selling) medication. Avastin generates more than $6 billion per year in global sales.
As Avastin is still on the market for other types of cancers, doctors will be able to use it off-label for breast cancer treatment. However, some health insurance companies may decide they will no longer cover the cost of the medication. At $88,000 per year, this move by insurers would put it out of the reach of a considerable percentage of patients.
Medicare says it will continue to cover the costs of Avastin if it is prescribed for breast cancer.
Hal Barron, M.D., chief medical officer and head of Global Product Development of Genentech, a member of the Roche Group, said:
"We are disappointed with the 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 in the United States.
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."
Many patients will be alarmed at Avastin's new regulatory status - they have been urging the FDA not to make the decision it has come to today, saying Avastin has helped keep them alive. Several Republican lawmakers say this is an example of a health care reform which is focusing on costs, rather than patient need.
Written by Christian Nordqvist