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Statement on Avastin
DALLAS -- August 17, 2010 -- Susan G. Komen for the Cure® and the Ovarian Cancer National Alliance are concerned about the potential impact on patients that could result from the Food and Drug Administration’s Oncology Advisory Panel’s recommendation to withdraw approval for bevacizumab. This agent, commonly known as Avastin, is a targeted therapy for patients with advanced breast cancer. We are concerned about patients who are presently receiving bevacizumab and the message that this decision sends about drug development in women with advanced breast cancer.
Avastin is an “anti-angiogenesis” drug, which means it blocks the formation of blood vessels that feed cancer tumors. Restricted blood flow helps slow the growth and spread of cancer. The drug has been approved for colon, brain, certain types of lung and other cancers. The panel’s recommendation does not affect the drug’s approval for those concerns.
In 2008, the FDA gave Avastin accelerated approval for the treatment of metastatic breast cancer (that is, breast cancer that has spread to other parts of the body) based on data showing that the drug extended the time it took for the cancer progress. Last month’s panel recommendation to withdraw approval was based on results from two relatively new clinical trials, which suggest that, on average, women taking the drug received only a modest benefit, while increasing their risk for certain side effects.
We recognize the benefits of Avastin overall are modest for women with metastatic breast cancer. However, we do know that for some women, Avastin offers a greater benefit — but we do not yet know how to determine which patients will experience greater benefits. We have much more to learn about the drug and how individual patients respond to the drug, such as why some women receive greater benefit while others do not.
Moving into the world of personalized medicine, cancer treatments will be more tailored to the characteristics of patients’ individual tumors. Yet, due to the current state of the science, we don’t always know which patients will benefit most before a drug is made commercially available. As with all medicines, we encourage a thoughtful discussion between a woman and her doctor that carefully considers the benefits and the risks. FDA approval is not a requirement for a doctor to prescribe a drug. However, the panel’s decision could limit the so-called “off-label” use of Avastin for metastatic breast cancer — or ovarian cancer, for which Avastin is currently prescribed off label — if third party payers refuse to cover the cost of treatment.
We are supportive of the drug development process and the route of accelerated approval for treatment of diseases such as metastatic breast cancer. We hope that drug manufacturers will continue to develop medications for the treatment of metastatic breast cancer, and would not want this decision to mean that drug development for breast cancer comes to a crashing halt. We will only succeed in finding new treatments for cancer by bringing new drugs to the clinic.
As patient advocate organizations, we call on all stakeholders — government, private industry, academia and the nonprofit community — to invest in the development of biomarkers and new drugs and to get the new technology and treatments to patients’ bedsides as safely and as quickly as possible. Further, we hope women who are currently being treated with Avastin for metastatic breast cancer or ovarian cancer continue to have access to the drug, and that third-party payers continue to cover it.