Washington D.C. – August 12, 2010. The Ovarian Cancer National Alliance (OCNA) and Susan G. Komen for the Cure® today urged the U.S. Food and Drug Administration to continue to allow the use of the drug bevacizumab, commonly known as Avastin, for metastatic breast cancer patients, noting that it is effective for many individuals.
In a joint letter sent to the FDA and key Congressional lawmakers Thursday, OCNA and Komen for the Cure wrote “we are particularly concerned about patients who are presently receiving bevacizumab and the message that this decision sends about drug development for women with advanced breast cancer.”
OCNA is concerned that an FDA label change will further restrict access to Avastin for ovarian cancer patients. Many women with ovarian cancer are receiving and benefitting from Avastin, although its use for ovarian cancer is “off label.” These women face another worry: Medicare has already rejected some requests for Avastin, one of the world’s most expensive but widely used cancer drugs. OCNA argues that Medicare and its contractors should pay for anti-cancer drugs that are listed on the approved compendia for Avastin.
“There is a fundamental fairness problem when the law is not being enforced equally,” says Karen Orloff Kaplan, CEO of the Ovarian Cancer National Alliance. “Medicare is obliged to pay for the costs of off label anti-cancer drugs listed on the approved compendia. We are concerned that a label change may create another barrier for treatment.”
Many doctors report patients taking Avastin enjoy “better than modest results” according to the joint OCNA-Komen letter to the FDA. In addition, a large scale Phase III trial showed an increase in progression free survival in women who used Avastin in combination with chemotherapy and as maintenance therapy for ovarian cancer.
The decision to use Avastin should be made between a woman and her doctor after a thoughtful conversation that carefully considers its benefits and risks. OCNA believes that women who have the potential to benefit from this drug should have access to it.
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 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 on this topic or to schedule an interview, please contact Georgi Morales via email at gmorales@ovariancancer.org or call (202)331-1332.
