2011.06.29 Advocates Concerned that FDA Decision on Avastin and Breast Cancer Will Harm Women with Ovarian Cancer

Washington, DC— Today, a panel of experts convened by the Food and Drug Administration (FDA) unanimously recommended that the label for Avastin (bevacizumab) no longer include metastatic breast cancer. The panel voted on four questions: if clinical trials on Avastin in metastic breast cancer showed benefit; if research showed that the drug is effective; if research showed that the drug is safe; and if the FDA should, regardless, keep the metastatic breast cancer label while the drug manufacturer conducts more studies. The panel voted unanimously that the data did not show benefit, safety or efficacy, and that the label should no longer include metastatic breast cancer.

Dr. Robert Burger testified before the FDA Oncologic Drugs Advisory Committee on behalf of Ovarian Cancer National Alliance on Tuesday, June 28. Responding to today’s decision, Alliance CEO Karen Orloff Kaplan expressed concern that the removal of metastatic breast cancer from the Avastin label will affect women with ovarian cancer, for whom the drug is used off-label.

“Results from three Phase III clinical studies show that Avastin is beneficial for some women with ovarian cancer, yet we hear from patients who are being denied insurance coverage for this treatment. We are deeply concerned that today’s ruling will make it even more difficult for women with ovarian cancer to access Avastin. The Ovarian Cancer National Alliance will continue our work to ensure that drugs that are useful and medically appropriate are available to women with this disease.”

Currently, most third party payers, including Medicare, reimburse for Avastin when used in the recurrent setting. However, the Ovarian Cancer National Alliance is concerned that this label change will lead to restrictions by payers. National compendia, including the NCCN compendia, include Avastin as a treatment for ovarian cancer.

The Ovarian Cancer National Alliance is the foremost advocate for women with ovarian cancer in the United States. To advance the interests of women with ovarian cancer, the organization advocates at a national level for increases in research funding for the development of an early detection test, improved health care practices, and life-saving treatment protocols.  The Ovarian Cancer National Alliance educates health care professionals and raises public awareness of the risks, signs and symptoms of ovarian cancer. The Ovarian Cancer National Alliance is a 501 (c) (3) organization established in 1997.

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For more information, or to schedule an interview, please contact Amanda Davis at adavis@ovariancancer.org or (202)331-1332.