FDA Recommends Removal of Breast Cancer Indication for Avastin

The US Food and Drug Administration (FDA) recommended late in 2010 to remove the breast cancer indication for bevacizumab (Avastin), because of a review of new data indicating that the drug has not been shown to be safe and effective for this patient population; specifically, the drug does not prolong overall survival and does not sufficiently slow the disease progression to warrant its associated adverse events, which include severe hypertension; bleeding and hemorrhage; perforations in the nose, stomach, and intestines; and heart attack or heart failure.

The FDA’s accelerated approval of bevacizumab was granted in February 2008, for use in combination with another cancer drug, paclitaxel. The current recommendation to remove the drug’s indication for metastatic breast cancer came after a near-unanimous (12:1) vote by an advisory committee comprised largely of oncologists who had reviewed 4 recent studies on bevacizumab in women with breast cancer. The manufacturer of the drug is in discussions with the FDA in the attempt to reverse this recommendation.

Although bevacizumab can still be used off label for the treatment of metastatic breast cancer, the question of whether insurance companies will cover it as an off-label use raises concerns for patients, considering the high cost of the drug.

The FDA recommends that oncologists currently treating patients with bevacizumab use their judgment in weighing the decision of whether to continue its use or switch to other therapies. Another concern involves patients who may wish to continue using this drug in the absence of other therapeutic options.

The FDA’s recommendation has also met with resistance from some oncologists and oncology groups. In October 2010, the National Compre - hensive Cancer Network confirmed the indication of bevacizumab for metastatic breast cancer in its updated breast cancer guidelines, despite the acknowledgment of the “lowlevel evidence” and the limited improvements in time to progression and response rates with the drug.

By contrast, the United Kingdom’s National Institute for Health and Clini cal Excellence announced in December that it would not support the use of bevacizumab for metastatic breast cancer because of insufficient evidence.