After determining that the drug is unsafe and ineffective for breast cancer treatment, the FDA recently revoked the agency’s approval of the breast cancer indication involving Avastin use in combination with paclitaxel for patients with HER2-negative breast cancer.
Severe high blood pressure; bleeding and hemorrhaging; heart attack or heart failure; and the development of perforations in different parts of the body such as the nose, stomach, and intestines are the risks included with the use of bevacizumab.
“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. But patients must have confidence that the drugs they take are both safe and effective for their intended use,” FDA Commissioner Margaret A. Hamburg, MD 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 either help them live longer or improve their quality of life.”
Despite the FDA’s recent decision, Medicare announced it would continue paying for bevacizumab for the treatment of breast cancer.
“Medicare will continue to cover Avastin,” Don McLeod, spokesman for the Centers for Medicare and Medicaid, said. “CMS will monitor the issue and evaluate coverage options as a result of action by the FDA but has no immediate plans to change coverage policies.”
Bevacizumab remains an approved therapy for certain types of colon, kidney, lung, and brain cancer (glioblastoma multiforme).