FDA revokes breast cancer indication for bevacizumab

November 18, 2011

FDA Commissioner Margaret A. Hamburg, MD, announced the agency's decision to revoke the breast cancer indication for bevacizumab (Avastin), noting that the benefits do not outweigh the potentially life-threatening side effects, such as heart attack or heart failure, high blood pressure, bleeding and hemorrhaging, and the development of perforations in different parts of the body, such as the nose, stomach, and intestines.

FDA Commissioner Margaret A. Hamburg, MD, announced the agency's decision to revoke the breast cancer indication for bevacizumab (Avastin), noting that the benefits do not outweigh the potentially life-threatening side effects, such as heart attack or heart failure, high blood pressure, bleeding and hemorrhaging, and the development of perforations in different parts of the body, such as the nose, stomach, and intestines.

Avastin has been used in combination with the cancer drug paclitaxel for patients who have not been treated with chemotherapy for their form of metastatic breast cancer known as HER2 negative. This indication must now be removed from the Avastin product labeling.

However, the drug is still approved for colon, lung, kidney, and brain cancer, Dr. Hamburg explained in a media conference call on November 18.

"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 that they take are both safe and effective for their intended use," Dr. Hamburg said.

After reviewing the 2 additional studies that the manufacturer, Genentech, completed following the accelerated approval of Avastin in February 2008, FDA concluded that the evidence failed to confirm a benefit in terms of delay of tumor growth, survival, or quality of life for women with metastatic breast cancer. "It is clear that there is no proof of benefit to justify the risks," she said.

Under the accelerated approval program, promising drugs have been made available to patients to treat serious and life-threatening conditions while confirmatory clinical trials are conducted, Dr. Hamburg said.

FDA's Center for Drug Evaluation and Research (CDER), which is responsible for the approval of Avastin, ultimately concluded that the evidence of the additional studies did not justify continued approval and notified Genentech of its proposal to withdraw approval for the breast cancer indication.

Genentech did not agree with the CDER's decision and requested a hearing on the CDER's withdrawal proposal. The 2-day hearing at the end of June 2011 included recommendations from the FDA's Oncologic Drugs Advisory Committee, which voted 6-0 to withdraw the breast cancer indication for Avastin. This was the first time that a manufacturer had challenged the FDA's decision on an accelerated drug approval and had requested hearings, Dr. Hamburg said.