FDA Revokes Approval for Avastin in Breast Cancer

The Food and Drug Administration (FDA) has revoked its approval of the drug Avastin for metastatic breast cancer after concluding that it “has not been shown to be safe and effective for that use.” The drug will remain an approved treatment for certain types of colon, lung, kidney and brain cancer. In June, an expert panel recommended the drug be withdrawn because there was no group of women with breast cancer who appeared to benefit from the drug, which has significant side effects and potential harms. In testimony, some women who say the drug has been keeping them alive had urged FDA to retain approval.

Here’s what  Len Lichtenfeld, M.D., who has been following this issue closely, had to say about the news.

“This announcement culminates a highly watched process where the FDA determined that although it had granted accelerated approval for the use of this drug in treating breast cancer, subsequent studies did not demonstrate in any group of women that Avastin actually helped patients in any meaningful way, while causing significant harms—including death. As difficult as this decision has been for the FDA, it is even more difficult for women who believe that Avastin has saved their lives.

“The full impact of this decision is difficult to determine at this time. This decision will obviously lead insurance companies to review their payment policies regarding Avastin in breast cancer. Other experts have made their opinions known that in their experience Avastin has proven beneficial for breast cancer patients. Whether those opinions will provide sufficient reason for insurers and government programs such as Medicare and Medicaid to pay for this treatment remains unknown. At the least, we would hope that insurers will continue to cover treatment with Avastin in those women with breast cancer currently on the drug and who are showing a benefit from its use.

“Ultimately, as noted by the Commissioner, this was a difficult decision to make, but one that had to be made based on the science.

“As we move forward in the era of targeted therapies, there are bound to be more situations where the expectations of scientists, doctors, and patients may not be borne out with further investigation. We can all hope for success, but when success is not confirmed by the science we must be willing to reconsider whether our hopes were in fact realities. That is neither simple nor easy, especially when dealing with human life. But it is a principle to which we must adhere if we are to be honest with ourselves, our patients, and those we serve.”


About David Sampson

I am the director of medical and scientific communications for the American Cancer Society national home office.
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