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Breast Cancer Survivor Decries Removal of Treatment Drug
web posted May 20, 2011
As a breast cancer survivor, I have closely followed any developments
in the diagnosis and treatment of the disease. Currently there is a
battle with the FDA over the use of Avastin for the treatment of
incurable metastatic breast cancer. Avastin is the only approved
antiangiogenic drug for MBC, meaning that the drug interferes with
blood flow, essentially starving tumors of their life-line. In
addition, the drug is at least as effective and shows fewer side
effects than other drugs approved by the FDA.
An estimated 17,500 breast cancer patients are taking the drug in the
United States. Some of these women are super-responders, who
would normally not be expected to live much longer without
Avastin. But the FDA has chosen to ignore these women and to only
concentrate on statistics and average results in their decision to
de-label the drug for breast cancer treatments after initially giving
Avastin approval under their fast track provision.
As a result, Medicare and private insurance companies will most likely
discontinue coverage for Avastin, which for most patients is
unaffordable. Genentech, the manufacturer of Avastin, has a
compassion fund to help the truly needy, but the FDA has adapted new
policies whereby drug companies could face liabilities for donating a
Ironically, the European Medicines Agency voted for use of Avastin with
certain chemotherapy. The FDA and EMA evaluated the same trials data,
but reached different decisions. So, a drug developed in San Francisco
gets approval for MBC in other countries, but not in America.
Genentech has been granted an appeal hearing by the FDA June
28-29. This is the last chance to prolong the lives of many
advanced breast cancer patients.
For more information, to sign the petition, or to sign up to protest at
the FDA HQ, please visit www.fameds.org.
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