FDA Recommends Withdrawing Avastin’s Approval for Breast Cancer

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J.B. Reed / Bloomberg News

The Food and Drug Administration (FDA) is recommending that the approval of Avastin for the treatment of breast cancer be revoked. The move comes after the agency reviewed the results of four clinical trials of the drug, and determined that its survival benefits did not outweigh its risks.

The FDA’s recommendation is not a surprise, since an advisory panel already voted 12-1 in July to remove the breast cancer indication from Avastin’s label.

The approval of Avastin (bevacizumab) was fast-tracked in February 2008, based on the results of a clinical trial of breast cancer patients who had not received chemotherapy. Since then, the drug has been used to treat patients in combination with chemotherapy, while the FDA awaited follow-up clinical-trial data from Genentech, the drug’s manufacturer. (More on Time.com: Top 10 Product Recalls)

“Subsequent studies failed to confirm the benefit observed in the original trial,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research in a statement. “None of the studies demonstrated that patients receiving Avastin lived longer and patients receiving Avastin experienced a significant increase in serious side effects. The limited effects of Avastin combined with the significant risks led us to this difficult decision. 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.”

According to the FDA, Avastin has been associated with several serious and potentially life-threatening side effects including “severe high blood pressure; bleeding and hemorrhage; the development of perforations (or ‘holes’) in the body, including in the nose, stomach, and intestines; and heart attack or heart failure.” Other complications include stroke, problems with wound healing, organ damage or failure, and a neurological condition called reversible posterior leukoencephalopathy syndrome (RPLS), which causes headaches, confusion, seizures and vision loss from swelling of the brain. (More on Time.com: Study: A Second Exam for Brain Death is Unnecessary — and Reduces Organ Donations)

Thursday’s announcement is the first step in revoking Avastin’s approval for breast cancer. The announcement notes:

Genentech has not agreed to remove the breast cancer indication voluntarily, so the agency has issued a Notice of Opportunity for a Hearing, which permits Genentech to request a public hearing if it wishes to contest the agency’s determination. The company has 15 days to request a hearing; if it does not do so, the hearing will be waived, and FDA will begin proceedings to remove the breast cancer indication.

For now, the FDA advises oncologists and breast-cancer patients who already using Avastin to continue doing so at their own discretion.

The drug will also maintain approval for treatment of patients with other types of cancer, including lung, colon, kidney and brain.

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