The Food and Drug Administration (FDA) has ruled to remove the breast cancer indication for Avastin (bevacizumab) because the drug has not proved safe and effective in studies among patients with breast cancer. The drug itself is not being removed from the market, and the FDA’s action will not immediately impact its use in treating breast cancer. The action also will not affect the approvals already in place for the drug in the treatment of colon, kidney, brain and lung cancers.

The FDA recommendation is based on the results of four clinical studies of Avastin in women with breast cancer. The agency found that the data from those studies indicate that Avastin does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing the disease progression to outweigh the significant risk to patients. In fact, the data showed that patients who took the drug didn’t live longer than patients who did not take the drug.

Patients on Avastin also experienced a significant increase in serious side effects including severe high blood pressure; bleeding and hemorrhage; the development of perforations (or holes) in the body, including the nose, stomach, and intestines; and heart attack or heart failure.

The FDA is recommending that oncologists currently treating patients with Avastin for metastatic breast cancer use their medical judgment when deciding whether a patient should continue treatment with the drug or consider other therapeutic options. Patients with questions about the drug or their treatment options should consult their oncologists.

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