FDA says Avastin does not work for breast cancer
Friday 17 December 2010
The US Food and Drug Administration said Thursday that Avastin is not an effective treatment for breast cancer and said it would take steps to revoke market approval and change the drug's label.
Acting on the advice of an expert panel earlier this year, the FDA said the drug, also known as bevacizumab, carries risks such as severe high blood pressure and hemorrhage and does not prolong overall survival in women suffering from breast cancer.
"The agency is recommending removing the breast cancer indication from the label for Avastin (bevacizumab) because the drug has not been shown to be safe and effective for that use," it said in a statement.
Other risks include "the development of perforations (or holes) in the body, including in the nose, stomach, and intestines; and heart attack or heart failure," the FDA said.
The independent advisory panel in July voted 12-1 to recommend that the FDA remove the indication from Avastin's label that the drug be used with chemotherapy to treat advanced breast cancer.
"After careful review of the clinical data, we are recommending that the breast cancer indication for Avastin be removed based on evidence from four independent studies," said Janet Woodcock, of FDA's Center for Drug Evaluation and Research.
"None of the studies demonstrated that patients receiving Avastin lived longer and patients receiving Avastin experienced a significant increase in serious side effects."
Avastin had been approved for treatment of advanced breast cancer under the FDA's accelerated approval program, which allows provisional approval of medicines for cancer or other life-threatening diseases.
The panel's recommendation did not affect the use of Avastin to treat other cancers, including colon and lung cancers.
Genentech, the Roche-owned pharmaceutical company that makes Avastin, said in a statement that it has been notified of the FDA's proposal to withdraw marketing approval for Avastin as a breast cancer treatment, and that it would request a hearing.
"Genentech will request a hearing. If FDA grants a hearing, there is no set date for when this would occur," it said om its website.
"Until the conclusion of these proceedings, Avastin remains FDA-approved for use in combination with paclitaxel for the first-line treatment of metastatic HER2-negative breast cancer," it said.
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