2011.11.18 Ovarian Cancer Advocates Troubled by FDA Decision on Avastin and Breast Cancer

Washington, DC—Today the Food and Drug Administration (FDA) announced that it would remove metastatic breast cancer from the label for Avastin (bevacizumab). This decision follows recommendations made in June by the FDA Oncologic Drugs Advisory Committee.

Responding to today’s decision, Alliance CEO Karen Orloff Kaplan, MSW, MPH, ScD, expressed concern that the removal of metastatic breast cancer from the Avastin label could negatively 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. We are deeply concerned that the Food and Drug Administration’s decision regarding metastatic breast cancer will make it difficult for women with ovarian cancer to access Avastin, and that patients could be denied insurance coverage for this treatment. 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 used when a woman’s cancer has returned. National compendia, including the NCCN compendia, include Avastin as a treatment for ovarian cancer. However, the Ovarian Cancer National Alliance is concerned that this label change will lead to restrictions by payers.

In June, Dr. Robert Burger testified before the FDA Oncologic Drugs Advisory Committee on behalf of Ovarian Cancer National Alliance. His testimony, which is available on the Alliance website, examined some of the reasons why overall survival is difficult to measure in clinical trials for ovarian cancer. The FDA cited a lack of evidence that Avastin improved overall survival for women with metastatic breast cancer in its decision. “Given how difficult it is to measure overall survival in ovarian cancer clinical trials, we are concerned that today’s ruling may set an unfortunate precedent,” said Dr. Kaplan.

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.