Washington, D.C., December 16, 2010 – The FDA announced today that it is beginning the process of removing breast cancer as an indication for the drug Avastin because the drug has not been shown to be safe and effective for that use. The FDA has made this decision after reviewing the results of four clinical studies of Avastin in women with breast cancer that show no improvement in overall survival and insufficient benefit in slowing disease progression to outweigh the significant risks to patients. The risks include severe high blood pressure; bleeding and hemorrhage; the development of perforations (or “holes”) in the body, including in the nose, stomach, and intestines; and heart attack or heart failure.
In addition to the risks identified in the trials, there is also troubling evidence that anti-angiogenic drugs such as Avastin, could actually make breast cancer worse. This possibility has been demonstrated in laboratory studies indicating that these drugs, though initially shrinking tumors, eventually lead to more extensive spread of disease (Paez-Ribes, 2009). We need to address this issue before we move forward and give these drugs to women.
We applaud the FDA for responding to the scientific evidence in the face of significant political and public pressure. Women deserve access to treatments that evidence proves effective. We understand how painful it is that we do not yet know how to cure metastatic disease. But we need to focus advocacy, public policy and resources on saving lives and doing more good than harm. Today's decision supports that approach.
The FDA’s decision further emphasizes the urgency of NBCC’s Breast Cancer Deadline 2020, which raises the bar as it aims to harness breast cancer resources toward ending this disease by January 1, 2020.
If you have a specific media request, please contact Michelle Zelsman, Director, Marketing and Communications at mzelsman@StopBreastCancer.org.
About the National Breast Cancer Coalition (NBCC)
The National Breast Cancer Coalition (NBCC) is dedicated to ending breast cancer by 2020 through the power of grassroots action and advocacy. NBCC increases funding for breast cancer research; monitors how those funds are spent; expands access to quality health care for all; and ensures that trained advocates influence all decision making that impacts breast cancer. Join NBCC, learn more and take action – visit www.BreastCancerDeadline2020.org.
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