Changes to Avastin (bevacizumab) use in breast cancer

Changes have been made to the indications of Avastin (bevacizumab) for use in breast cancer therapy in the US and Europe. Avastin is an anticancer agent that is used in the treatment of colorectal cancer, breast cancer, non-small cell lung cancer, renal cell carcinoma and glioma.1

In the US, the Food and Drug Administration (FDA) has removed breast cancer from the indications for Avastin. The FDA made the change after reviewing four clinical studies and determining that the risks of using Avastin for breast cancer outweigh the benefits. In these studies, patients who received Avastin experienced significant side effects but no prolongation of survival.²

The European Medicines Agency (EMA) has also completed a review of Avastin. In contrast to the FDA’s findings, the EMA has concluded that Avastin in combination with paclitaxel is still a viable treatment option for breast cancer. However, Avastin is not approved in combination with docetaxel or capecitabine for breast cancer. New data has thrown into question the effect of Avastin in combination with docetaxel on progression-free survival and overall survival. This data has led the EMA to remove this combination from the indications. Capecitabine in combination with Avastin was deemed to have only modest benefits that do not outweigh its high toxicity.³  

In Australia, Avastin in combination with paclitaxel is indicated for first-line treatment of metastatic breast cancer in patients for whom anthracycline-based therapy is contraindicated.¹

References

1. Australian public assessment report for bevacizumab. Woden, ACT: Australian Government Therapeutic Goods Administration; March 2010. Available from: URL link
2. FDA begins process to remove breast cancer indication from Avastin label [online]. Silver Spring, MD: US Food and Drug Administration; 16 December 2010 [cited 17 January 2011]. Available from: URL link
3. European Medicines Agency completes its review of Avastin used in breast cancer treatment [online]. London: European Medicines Agency; 16 December 2010 [cited 17 January 2011]. Available from: URL link

More information

For more information on breast cancer, types of breast cancer and its investigations and treatments, as well as some useful videos, see Breast Cancer.