Breast Cancer Drug Revoked for “Life-Threatening” Risks

The government revoked the approval of breast cancer drug Avastin last week, citing dangerous side effects and a lack of evidence that it prolongs life. FDA Commissioner Margaret Hamburg said it was a “difficult decision,” referencing the patients who have been lobbying to keep the drug.

But, she added that “it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth, that would justify those risks.”

Risks include severe high blood pressure, massive bleeding, heart failure, and perforations in parts of the body such as the stomach and intestines. The FDA’s decision may prompt a review of industry guidelines from groups like the National Comprehensive Cancer Network, which represents leading cancer treatment centers.

Although FDA formally revoked its approval of the drug to treat breast cancer, doctors still could prescribe it — but insurers may not pay for it. Including infusion fees, a year’s treatment with Avastin can cost $100,000.

What do you think of the Avastin decision?

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