National Cancer Institute NCI Cancer Bulletin: A Trusted Source for Cancer Research News
July 12, 2011 • Volume 8 / Number 14

FDA Update

Advisory Panel Upholds Recommendation to Withdraw Bevacizumab Approval for Breast Cancer

A panel of experts advising the Food and Drug Administration (FDA) recommended unanimously that the agency withdraw its accelerated approval of bevacizumab (Avastin) for treating metastatic breast cancer. FDA Commissioner Dr. Margaret A. Hamburg will make a final decision on whether to implement the panel’s recommendation after a period of public comment. (Electronic or written comments must be submitted to by July 28.)

Members of the Oncologic Drugs Advisory Committee (ODAC) of the FDA’s Center for Drug Evaluation and Research recommended withdrawing the approval on June 29. In a series of three votes, panel members agreed with the FDA that bevacizumab should no longer be approved for use with chemotherapy as a first-line treatment for HER2-negative metastatic breast cancer.

The FDA granted accelerated approval for this indication in February 2008 based on the results of a single phase III clinical trial. However, such approvals are contingent on the results of additional, confirmatory trials. Last July, after reviewing the results of two additional clinical trials, ODAC voted 12 to 1 to recommend against the use of bevacizumab for metastatic breast cancer. (See: FDA Advisory Committee Recommends against Bevacizumab for Metastatic Breast Cancer.)

Genentech, a division of Roche and the manufacturer of bevacizumab, was granted an appeal hearing. Representatives of the company, as well as patients and breast cancer advocates, spoke during the 2-day meeting held in Silver Spring, MD.

In the first of three 6–0 votes, the advisory panel agreed with FDA officials that the ongoing trials have not demonstrated a clinical benefit with bevacizumab for participants in the trials. The panel also agreed that the available evidence did not show that bevacizumab was safe in this setting—that is, the risks outweighed the benefits for breast cancer patients. (Cancer patients who receive bevacizumab in combination with chemotherapy may be at an increased risk of serious side effects that may lead to death.)

Finally, the panel recommended against the continued approval of the drug for metastatic breast cancer while the sponsor, Genentech, conducts another study intended to verify the drug’s clinical benefit.

Bevacizumab is approved for treating other cancers, including advanced colorectal, lung, kidney, and brain cancers. Until the FDA commissioner makes a decision, bevacizumab remains an approved drug for use with paclitaxel in women with HER2-negative metastatic breast cancer. 

Further reading: Questions and Answers about Avastin