FDA Avastin Breast Cancer Review Extended 90 Days

Federal drug regulators have extended their review of whether Avastin should remain available as a treatment option for breast cancer by 90 days, until December 17.  

Roche announced the decision last Friday, the day FDA was expected to decide whether to withdraw breast cancer approval for the drug. Avastin was given approval for breast cancer treatment in 2008 in a fast-track process that did not require extensive clinical trials, but post-marketing studies suggest that the drug’s benefits may be limited for breast cancer patients and outweighed by Avastin side effects. The FDA is weighing whether it made a mistake in giving Avastin approval for breast cancer treatment.

In July, an FDA advisory panel voted 12-1 to recommend that the FDA withdraw Avastin’s breast cancer approval. Although the FDA is not required to follow the recommendations of their advisory panels, they often do. If approval is withdrawn for breast cancer treatment, an Avastin recall would not be issued, as the drug would still be approved for the treatment of kidney, colon, lung and brain cancer.

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.

Further studies have failed to show that Avastin extends the lives of breast cancer patients, and it does not appear to actually reduce tumors that are already present. The post-market clinical trials also seem to indicate that the drug’s ability to slow tumor growth is not as pronounced as the initial trials suggested.

About 6,000 breast cancer patients who use Avastin have signed a petition asking the FDA to allow the drug to keep its approval for breast cancer treatment. While losing the approval would not prevent doctors from prescribing Avastin for breast cancer, it does prevent Roche and Genentech from promoting it for such uses. It also allows insurance companies to deny reimbursement for the cost of the drug. That would leave many patients unable to afford the expensive medication.