The FDA has announced that it is recommending the removal of the breast cancer indication from the label for Avastin (bevacizumab, from Genentech) because the drug has not been shown to be safe and effective for that use. The FDA is making this recommendation after reviewing the results of four clinical studies of Avastin in women with breast cancer and determining that the data indicate that the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients. These risks include severe hypertension; bleeding and hemorrhage; the development of perforations in the body, including in the nose, stomach, and intestines; and heart attack or heart failure.

After the accelerated approval of Avastin for breast cancer in combination with paclitaxel in February 2008, Genentech completed additional clinical trials and submitted the data from those studies to the FDA. These data showed only a small effect on “progression-free survival” without evidence of an improvement in overall survival or a clinical benefit to patients sufficient to outweigh the risks. The small increase in “progression-free survival” reflects a small, temporary effect in slowing tumor growth.

Oncologists currently treating patients with Avastin for metastatic breast cancer should use their medical judgment when deciding whether a patient should continue treatment with the drug or consider other therapeutic options. The FDA has informed Genentech of its proposal to withdraw marketing approval of Avastin for breast cancer. Genentech has not agreed to remove the breast cancer indication voluntarily, so the FDA has issued a Notice of Opportunity for a Hearing. Genentech will request a public hearing. If the FDA grants a hearing, there is no date set for when this will occur. Until the conclusions of the proceedings, Avastin remains FDA-approved for use in combination with paclitaxel for the first-line treatment of metastatic HER2-negative breast cancer.

This recommendation does not affect the approvals for Avastin in colon, kidney, brain, and lung cancers.

For more information visit www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm237172.htm.