Avastin Health Risks Lead To Removal of Breast Cancer Approval

Federal regulators have announced that the cancer drug Avastin will soon lose its approval for the treatment of breast cancer in the United States. 

The decision to revoke Avastin’s indication for breast cancer treatment was announced by the FDA on Thursday and comes after a review that shows that the drug does little to help breast cancer patients.

There are a number of potential Avastin side effects, which the FDA has decided outweigh the drug’s limited health benefits. The potential health risks of Avastin may include severe high blood pressure, heart attacks, heart failure, bleeding and hemorrhaging, and the development of perforations in the nose, stomach and intestines.

The revocation will not happen immediately. Genentech will have 15 days to request a hearing in writing challenging the decision. If the company chooses to do so, there will be a hearing open to the public where the company can present evidence to the FDA to attempt to sway the agency from removing Avastin breast cancer approval.

Doctors will still be able to prescribe Avastin for breast cancer treatment, however it is unlikely that most insurance companies would cover the drug’s use, driving the cost out of reach for most patients.

Some women have said that Avastin has worked well on their breast cancer, but the FDA said that it must rely on the clinical trials and not anecdotal evidence. FDA officials said that there could be any number of reasons some women have seen significant cancer benefits while on Avastin that are not linked to the drug’s effectiveness.

Avastin (bevacizumab) was approved by the FDA in 2004 for treatment of non-small cell lung cancer and colorectal cancer when combined with chemotherapy. It was then was granted accelerated approval for use with paclitaxel to treat breast cancer patients by FDA in February 2008. The drug prevents the formation of new blood vessels in tumors, starving them and inhibiting their growth.

The approval of Avastin for breast cancer treatment was based on a clinical trial finding that it slowed the growth of breast cancer tumors, at odds with the usual requirement that breast cancer treatment drugs show that they actually extend the lives of patients. As part of the accelerated approval process, Genentech, a subsidiary of Roche, had to continue two more drug trials and then submit their findings to FDA.

In July, an FDA advisory committee voted 12-1 to remove the breast cancer indication. However the advisory committee’s vote is non-binding and the FDA had to come to its own conclusion. Drug reviewers looked at clinical data from four independent studies, and found that the use of Avastin did not significantly extend the lives of breast cancer patients, and had little effect on tumors.

“None of the studies demonstrated that patients receiving Avastin lived longer and patients receiving Avastin experienced a significant increase in serious side effects,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “The limited effects of Avastin combined with the significant risks led us to this difficult decision. The results of these studies are disappointing.”

Woodcock said that the FDA encouraged Genentech to conduct additional research to identify any specific groups of patients that might derive a benefit from using Avastin to treat breast cancer.

The FDA’s decision will not result in an Avastin recall, as the medication remains approved for other uses.