FDA Recommends Avastin Not Be Approved for Metastatic Breast Cancer

By Ilene Winkler

From Mets Matters Blog

The FDA announced today that they are recommending that Avastin not be approved for women with metastatic breast cancer. I listened to a conference call they held to explain their decision and take questions from advocates. Here's a summary of what they said:

Avastin, made by Genentech, was approved in 2008 for first-line treatment of women with metastatic disease under a process called "accelerated approval," meaning that the drug was conditionally approved pending final results of clinical trials. The first clinical trial, named E2100, showed a 5 1/2 month improvement in progression-free survival (time until the cancer came back) for Avastin and Taxol compared to Taxol alone, based on xrays and scans of the patients in the trial. There was no improvement in overall survival.

Since then, Genentech has reported on the results of three large trials of Avastin combined with Taxotere (the AVADO trial) or chemo (trials called Ribbon2 and AVF 2119G). These trials did not show more than a one-month improvement in progression-free survival or any improvement in overall survival. They also did not show a measurable improvement in patient-reported outcomes such as quality of life or symptom control.

However, the trials all showed a 14-20% increase in severe and life-threatening side effects, including severe high blood pressure, heart failure, and intestinal and other perforations.

The FDA has therefore concluded that based on the scientific evidence, the benefits do not justify the risks of Avastin for patients with metastatic breast cancer. They will continue to approve Avastin for other cancers including colorectal and renal cancers, where it is more effective.

Here's some important information you should know right now:

• Nothing is changing until Genentech has a chance to ask for another hearing. Avastin is still approved for now as a first-line treatment for metastatic breast cancer.
• The FDA says they will work with Genentech to ensure that women who are doing well on Avastin will continue to get the drug even if it is not approved for new patients.
• The clinical trials have not shown that Avastin works better for any group of women such as triple negative or younger women. But since some women do well on the drug, the FDA wants to work with Genentech to continue trying to identify why the drug works for some women and not others.
• The FDA says they did not take the cost of Avastin into account in making this decision.

If you are interested in learning more on this subject, you can go to the FDA press release or the Genentech press release.

What do you think of the FDA's decision? We'd like to hear from you, especially if you have taken Avastin.

Posted December 16, 2010.