FDA Moves Forward to Remove Avastin for Breast Cancer Treatment

Kathleen Blanchard's picture

An FDA panel voted 12 to 1 to remove labeling for Avastin as a treatment for breast cancer, in a first step that could ban the drug altogether as a therapy for the disease. They also encourage the manufacturer, Genentech, to conduct more studies.

Avastin Studies "Disapponting" says FDA

The FDA says, “The results of these studies are disappointing. We encourage the company [Genentech] to conduct additional research to identify if there may be select groups of patients who might benefit from this drug.”

The FDA has issued a Notice of Opportunity for a Hearing and notified the company of its proposal to remove the Avastin indication for breast cancer treatment. Genentech can request a public hearing within 15 days. If the company fails to do so the FDA would proceed. The company had not agreed to voluntary remove the indication for the drug.

Genentech's Sandra Horning, M.D., Senior Vice President, Global Head of Hematology/Oncology says the FDA is “potentially taking away a choice for the thousands of women facing the disease.” Dr. Horning is also a breast cancer survivor. She says for women with incurable breast cancer “there is clearly a need for multiple treatment choices. She says Genentech plans to ask the FDA for a hearing.

The decision to remove the breast cancer indication for the drug came mostly from oncologists on the FDA advisory board who say the risks of the drug outweigh the benefits, but it doesn’t mean the drug can’t be used. The FDA says, “Oncologists treating patients with Avastin for metastatic breast cancer should exercise medical judgment about switching to another agent or continuing Avastin.


The proposal comes after the FDA reviewed four clinical trials that failed to show Avastin prolongs survival time for women with breast cancer.

Avastin side effects include gastrointestinal perforation that can be fatal; problems with wound healing that can also lead to death, blood clots, hypertension, stroke and heart attack, seizures, brain swelling with vision loss and organ damage.

Avastin is currently approved for treatment of HER2 negative metastatic breast cancer, colon, lung and kidney cancer in combination with other therapies.

The initial accelerated approval of Avastin for treating breast cancer, combined with the chemotherapy drug paclitaxel came about in 2008 when a clinical trial known as “E2100” showed women who had not been give chemotherapy for metastatic HER2-negative breast cancer showed promise.

The accelerated approval process is designed to give patients access to potential treatment until more studies are conducted. Ensuing studies submitted to the FDA failed to show the drug prolonged breast cancer survival, except in a few instances of “slower tumor growth” that was temporary.

The FDA says there may be a population of women who would benefit from Avastin and they remain open to more research proposals from Genentech. Based on a review of the clinical data submitted, the FDA determined Avastin risks outweigh the benefits for treating breast cancer.