FDA Recommends Removing Breast Cancer Indication from Avastin
Article date: December 16, 2010
By Eleni Berger
The US Food and Drug Administration recommends removing the approval of the drug bevacizumab (Avastin) to treat breast cancer, the agency announced today. The FDA said Avastin has not proven to be as safe or effective for treating breast cancer as it was thought to be from the early studies.
The drug is not being removed from the market, and this decision will not have an immediate effect on the use of the drug in treating breast cancer. The agency advised doctors treating breast cancer patients with Avastin to use their medical judgment to decide whether to continue the drug or try something else.
Few benefits, many side effects
An advisory panel for the FDA recommended withdrawing Avastin for breast cancer after large studies showed it delayed progression of the disease by less than a month while causing more serious side effects than chemotherapy alone. The drug did not help women with breast cancer live longer in these studies.
The serious side effects included bleeding, high blood pressure, stroke, health attack and heart failure, wound-healing complications, and holes (perforations) in the stomach, nose, and intestines. Less serious side effects included headache, irritated nose, protein in the urine, taste alteration, dry skin, rectal bleeding, and skin inflammation.
“The limited effects of Avastin combined with the significant risks led us to this difficult decision,” Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “The results of these studies are disappointing. We encourage the company to conduct additional research to identify if there may be select groups of patients who might benefit from this drug.”
Bevacizumab, made by Genentech, was first approved to treat breast cancer in 2008. But because there were still questions about its benefits, the company agreed to conduct further tests after approval.
Revoking approval a lengthy process
Today’s announcement is only the first step toward revoking Avastin’s approval for breast cancer treatment, the FDA said. The decision does not affect the use of bevacizumab for other types of cancer. It is approved for treating colorectal, kidney, and non-small cell lung cancers, and certain brain tumors.
Genentech has 15 days to request a public hearing to challenge the FDA’s decision. If the company does not take action, the FDA will continue the process of removing approval for breast cancer.
Genentech Senior Vice Preseident Sandra Horning, MD, said the company plans to ask the FDA for a hearing.
"Many people in the United States are diagnosed with an advanced cancer that is not curable. For these individuals there's clearly a need for multiple treatment choices," Horning said in a statement. "That's why we will ask the FDA for a hearing and continue to work to maintain the ability for doctors and patients to make an informed choice."
The agency said it is willing to work with Genentech to conduct more studies of Avastin in breast cancer patients to see if there are some women who might benefit from the drug.
"Clearly some women with metastatic breast cancer have benefitted from Avastin, but others not only have not benefitted, they've been harmed," said Len Lichtenfeld, MD, American Cancer Society deputy chief medical officer. "What we clearly need is a way for doctors to more accurately predict which women will have a better chance of benefitting from this important targeted therapy. Until that tool is developed, giving all women with metastatic breast cancer Avastin may harm more women than it helps.”
Women currently taking bevacizumab for breast cancer should speak with their doctor about the best course of action.
ACS News Center stories are provided as a source of cancer-related news and are not intended to be used as press releases.
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