FDA Questions Benefit of Roche's Avastin for Breast Cancer


The US Food and Drug Administration (FDA) is reviewing data about the risks versus benefits of using Roche Holding AG’s Avastin (bevacizumab) for breast cancer. The drug was approved to treat the most common type of advanced breast cancer in 2008, and is also used in the treatment of other cancers, such as colon, non-small cell lung, kidney, and brain cancer.

The FDA said that the improvement seen among women being treated with Avastin plus chemotherapy is “not clinically meaningful” over giving chemotherapy alone. The agency is also concerned about serious side effects, such as high blood pressure, fatigue and loss of white blood cells, among women receiving Avastin.

The "risk-benefit ratio of [Avastin] when added to the standard chemotherapeutic regimens...may not be considered favorable," the agency said.


In 2008, Avastin was approved to treat HER2/neu negative metastatic breast cancer when used in combination with paclitaxel under the “accelerated approval” program. The drug works by interfering with a protein that forms blood vessels in the tumors.

The main study that supported the approval of Avastin showed that using the drug with paclitaxel added five and a half months to median progression-free survival. The study did not show a statistically significant increase in overall survival.

Subsequent studies have “failed to confirm the magnitude” of the benefit seen in the first study, according to the FDA.

Roche maintains that Avastin is “safe and effective” and is currently seeking expanded approval for its use in combination with other types of chemotherapy drugs.

An oncology drug advisory committee is expected to meet next Tuesday to discuss the future of Avastin for breast cancer treatment. The final decision is expected to be made by September.