Committee Recommends Withdrawal of Breast Cancer Indication From Bevacizumab

July 25, 2011
Jamie L. Habib
Jamie L. Habib

FDA approval for bevacizumab (Avastin) as treatment for metastatic HER2-negative breast cancer should be withdrawn, according to a unanimous vote (6-0) of the FDA’s Oncologic Drug Advisory Committee. The committee convened at the request of the drugmaker (Genentech) to appeal an earlier decision by the FDA to remove the indication for bevacizumab to treat locally recurrent or metastatic HER2-negative breast cancer.

FDA approval for bevacizumab (Avastin) as treatment for metastatic HER2-negative breast cancer should be withdrawn, according to a unanimous vote (6-0) of the FDA’s Oncologic Drug Advisory Committee.1 The committee convened at the request of the drugmaker (Genentech) to appeal an earlier decision by the FDA to remove the indication for bevacizumab to treat locally recurrent or metastatic HER2-negative breast cancer. However, the committee endorsed the earlier decision after unanimously concluding that the drug neither works nor is safe.

Ultimately, FDA Commissioner Margaret Hamburg, MD, will decide whether to remove breast cancer as an approved indication for bevacizumab. Even if she agrees with the committee’s decision, the drug would still be approved for the treatment of metastatic colorectal cancer, metastatic nonsquamous non-small cell lung cancer, metastatic renal cell carcinoma, and as second- or third-line treatment for glioblastoma multiforme. Because the drug would still be on the market, physicians would be able to prescribe it off-label for breast cancer.

Of concern to women with breast cancer who seem to respond well to bevacizumab is that their insurance companies will no longer cover the cost of the drug (about $8000 per month) if breast cancer is no longer an FDA-approved indication. However, Medicare will continue to cover bevacizumab for breast cancer even if the FDA removes that indication from the labeling, according to a CMS spokesperson.2 Both Medicare and private insurance companies cover off-label uses for drugs if they are considered medically necessary, and private insurance companies generally take their coverage cues from Medicare.2

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