Cancer drug Avastin should no longer be used in breast cancer patients, a board of cancer experts representing the Food and Drug Administration ruled Wednesday for a second time.
The decision came less than a year after the same panel made the same conclusion, Fox News reports.
Although a handful of breast cancer patients testified that
Avastin helped in treating their metastatic breast cancer, the six panel members voted unanimously that Avastin's risks outweighed the benefits and its approval should be withdrawn.
"I think we all wanted Avastin to succeed
but the reality is that these studies did not bear out that hope," said
Natalie Compagni-Portis, the lone patient representative on the FDA
panel, as reported by Fox News.
Although the vote is not binding and FDA Commissioner Margaret Hamburg will make the final decision, outraged patients in the audience shouted at the FDA panelists after the decision was made.
"What do you want us to take!? We have nothing else!" shouted Christi
Turnage, of Madison, Miss. Turnage said her cancer has been undetectable
for more than two years since starting therapy with Avastin, Fox News reports.
The FDA granted an accelerated conditional approval for Avastin in
February 2008 to treat late-stage breast cancer patients, ABC News reports. It had been
suggested that the drug slowed the progression of the disease and
improved overall survival.
But results from four trials that enrolled more than 3,000 women found
no significant reduction in progression of the disease or improvement of
death rates among those who took Avastin and underwent chemotherapy, ABC News reports.
Avastin is FDA-approved for various types of colon, lung, kidney and brain cancer,
which are not part of the debate. Doctors will still be allowed to
prescribe Avastin for breast cancer, though insurers may not pay for it, Fox News reports.
Avastin Should No Longer Be Used On Breast Cancer Patients, FDA Says
Jun 29, 2011, 14:09 by Sarah Long