FDA Moves to Drop Avastin Breast Cancer Indication - MedPage Today

WASHINGTON -- The FDA has begun the process of removing the breast cancer indication for bevacizumab (Avastin).

Citing a lack of evidence of safety and effectiveness from four clinical trials, the agency decided 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 decision follows an FDA advisory committee's 12-1 vote in July to recommend removal of the indication for metastatic breast cancer

At a news briefing to announce the decision, Janet Woodcock, MD, director of the FDA Center for Drug Evaluation and Research, offered a bottom-line assessment about the rationale for seeking to remove the breast cancer indication.

"None of the four trials showed any survival benefit," said Woodcock. "They did not show that adding Avastin to a variety of chemotherapy regimens prolongs the life of women with metastatic breast cancer, but added many serious side effects."

via medpagetoday.com

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