FDA Panel Votes to Reject Avastin for Breast Cancer

Article date: June 30, 2011

By Stacy Simon

An advisory panel voted Wednesday to recommend that the Food and Drug Administration (FDA) withdraw approval for bevacizumab (Avastin) to treat advanced breast cancer. The panel found that the drug was not effective and caused dangerous side effects. The final decision will be made by the commissioner of food and drugs.

The vote came after a 2-day hearing that included presentations by members of the public, drugmaker Genentech and the FDA’s Oncologic Drugs Advisory Committee. Many of the presenters were breast cancer survivors who said Avastin had saved their lives, and pleaded with the FDA not to withdraw approval.

The FDA’s decision won’t affect the approval of Avastin for other cancers. It’s approved for treating colorectal, kidney, non-small cell lung cancers and certain brain tumors.

Doctors would still be able to prescribe the drug to breast cancer patients, but that use would be considered "off-label." Some of the survivors who testified speculated that insurance companies would stop paying for this off-label use of Avastin.

Discouraging Results from Follow-up Studies

Avastin was fast-tracked to treat advanced breast cancer in 2008 after early studies showed it was successful in slowing progress of the disease, though the studies did not show an improvement in survival. As a condition of the approval, Genentech was required to conduct more trials to demonstrate its safety and effectiveness. But the results of those trials did not show that women taking Avastin lived longer. And unlike the earlier studies, the new trials did not demonstrate significant slowing of the disease growth.

In addition, many women experienced serious side effects, including bleeding, high blood pressure, stroke, heart attack and heart failure, wound-healing complications, and perforations (holes) in the stomach, nose and intestines. Less serious side effects included headache, irritated nose, protein in the urine, taste alteration, dry skin, rectal bleeding and skin inflammation.

As a result, the FDA began last December to remove the breast cancer indication for Avastin. Genentech then requested the public hearing to challenge the FDA’s decision.

The FDA’s final decision on whether to withdraw its approval will not be made for several weeks. Women who are taking Avastin for breast cancer should talk to their doctors about what to do. For more information about breast cancer treatment, see our detailed guide.

Reviewed by: Members of the ACS Medical Content Staff

ACS News Center stories are provided as a source of cancer-related news and are not intended to be used as press releases.