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FDA rules to remove breast cancer indication from bevacizumab
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The FDA has announced that the breast cancer indication will be removed from the bevacizumab label due to the drug’s inability to demonstrate safety and efficacy in this population.
Genentech has been notified of the FDA’s decision about bevacizumab (Avastin) but will not remove the breast cancer indication voluntarily. Therefore, the FDA has issued a Notice of Opportunity for a Hearing to allow the company to request a public hearing to contest the agency’s decision. The hearing will be waived and the FDA will take action to remove the breast cancer indication if Genentech does not respond within 15 days of the notice.
“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,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a press release. “Subsequent studies failed to confirm the benefit observed in the original trial. 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, this is the first step in the process of removing the breast cancer indication from the bevacizumab label. However, the drug is not being pulled from the market and the other indications — colon, kidney, brain and lung cancers — will not be affected. Oncologists are advised to use their medical judgment when determining whether to continue treatment with bevacizumab among patients with metastatic disease.
In February 2008, bevacizumab received accelerated approval for breast cancer in combination with paclitaxel. However, studies submitted by Genentech after receiving approval demonstrated little effect on PFS without evidence of improvement in OS, or a clinical benefit that outweighed the risks. The drug was also associated with serious side effects, including stroke, wound healing complications, organ damage or failure and the development of reversible posterior leukoencephalopathy syndrome, according to the press release.
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