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FDA Delays Decision on Breast Cancer Indication for Bevacizumab

Zosia Chustecka


September 17, 2010 — The US Food and Drug Administration (FDA) has decided to extend its review of bevacizumab (Avastin) in the treatment of breast cancer, delaying its decision on whether to revoke the license for this indication. The new date for the decision has been set for December 17, 2010.

There has been frenzied speculation all day that the FDA may revoke the breast cancer indication, a move that was recommended recently by an FDA advisory committee. The committee had voted nearly unanimously for such an action, citing doubts over benefit of the drug, and in particular highlighting the lack of overall survival advantage.

There have been protests against withdrawing the indication by both breast cancer specialists and patients. Others claimed that the cost of the drug was influencing a decision that should be made purely on efficacy and safety grounds.

Revoking the indication would "remove an important treatment option from patients with metastatic breast cancer," commented Gabriel Hortobagyi, MD, FACP, professor of breast medical oncology at the University of Texas M.D. Anderson Cancer Center, who was present at the advisory meeting in July as a consultant to Genentech.

The drug is "clearly active in breast cancer," he told Medscape Medical News at the time. "Anecdotally, bevacizumab combinations can produce dramatic responses in individual patients, and it is my clinical impression that responses of such quality are seldom seen with the same chemotherapy programs without bevacizumab."

A huge petition with 6500 signatures has been sent to the FDA asking for bevacizumab to remain available for breast cancer. Headed by Christi Turnage, MSN, RN, who herself has been taking the drug for her breast cancer and is now 27 months progression-free, the petition collected signatures from patients, women, and others concerned about the issue.

The petition has been featured prominently in influential news media, often alongside profiles of breast cancer patients who are doing well on bevacizumab. At the same time, there have been several allusions in the media to "death panels" restricting what is being described as a life-saving drug, even though bevazicumab has not been shown to extend survival in breast cancer. In yesterday's Wall Street Journal, a breast cancer patient wrote that the FDA "may withdraw the drug that is keeping me alive."

However, there were also arguments for the withdrawal of the indication. From a sample of oncologists and healthcare professionals who voted in a recent poll on Medscape Oncology, the vast majority (89%) felt that an FDA decision to withdraw the indication for bevacizumab in breast cancer would be appropriate.

That poll appeared in the "Blowing Smoke" blog, authored by Howard (Jack) West, MD, medical oncologist at the Swedish Cancer Institute in Seattle.

In a recent entry, Dr. West had emphasized that new drugs for lung cancer have almost exclusively been evaluated on their ability to improve overall survival, and he asked why the situation should be different in other types of cancer.

One of the main issues with bevacizumab in breast cancer is that it has never shown an overall survival benefit, only a benefit of progression-free survival, and in some studies, even this was small.

"It's hard for me to understand why we should have different acceptable end-points for accepting wildly expensive medications depending on whether they are treating one cancer or another," Dr. West wrote.

"It's hard to look at the oncology landscape and not think that society basically feels that some cancers are simply more worth treating than others," he commented.

Authors and Disclosures


Zosia Chustecka

Zosia Chustecka is news editor for Medscape Hematology-Oncology and prior news editor of, a Web site acquired by WebMD. A veteran medical journalist based in London, UK, she has won a prize from the British Medical Journalists Association and is a pharmacology graduate. She has written for a wide variety of publications aimed at the medical and related health professions. She can be contacted at

Zosia Chustecka has disclosed no relevant financial relationships.

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