DeLauro on FDA Avastin Announcement
December 16, 2010
Washington, DC— Congresswoman Rosa L. DeLauro (CT -3), Chairwoman of the FDA and Agriculture Appropriations Subcommittee, released the following statement today in response to the announcement by the Food and Drug Administration (FDA) that it is recommending removing the breast cancer indication from the label for Avastin because the drug has not been shown to be safe and effective for that use.
The FDA made this recommendation after reviewing the results of four clinical studies of Avastin in women with breast cancer and determining that the data indicate that the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients.
"The FDA has made the appropriate decision in beginning the process to remove the breast cancer indication from the Avastin label. Based on the confirmatory trials sponsored by the manufacturer, the scientific evidence available seems to be clear that the drug does not prolong life or improve the quality of life, and often does more harm than good— critical evaluation criteria for assessing a cancer drug's effectiveness.
"While this decision is disappointing to some breast cancer patients who believe Avastin has helped them, it is imperative that these patients receive treatments that provide benefits, and prolongs their lives. Just as scientific evidence compelled the FDA to act on Avandia, the agency is acting on Avastin based on scientific data."
The FDA made this recommendation after reviewing the results of four clinical studies of Avastin in women with breast cancer and determining that the data indicate that the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients.
"The FDA has made the appropriate decision in beginning the process to remove the breast cancer indication from the Avastin label. Based on the confirmatory trials sponsored by the manufacturer, the scientific evidence available seems to be clear that the drug does not prolong life or improve the quality of life, and often does more harm than good— critical evaluation criteria for assessing a cancer drug's effectiveness.
"While this decision is disappointing to some breast cancer patients who believe Avastin has helped them, it is imperative that these patients receive treatments that provide benefits, and prolongs their lives. Just as scientific evidence compelled the FDA to act on Avandia, the agency is acting on Avastin based on scientific data."