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SILVER SPRING, Md. — Just a few months after a Food and Drug Administration advisory committee recommended limiting the use of a Genentech drug designed to treat breast cancer, the regulatory agency is looking to revoke the approval altogether.
The FDA on Thursday said it was in the process of removing the breast cancer indication from Avastin (bevacizumab) after reviewing the results of four clinical studies, which indicated 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 agency said.
The FDA issued its proposal to withdraw the drug to Genentech. The drug maker has the opportunity to request a public hearing if it wishes to contest the agency’s determination.
“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, director of the FDA’s Center for Drug Evaluation and Research. “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.”
In July, the Oncologic Drugs advisory committee voted 12-to-1 that use of Avastin (bevacizumab) combined with paclitaxel chemotherapy as a first-line treatment for advanced HER2-negative breast cancer be removed from the drug’s labeling.