The widespread reporting of the recommendation to withdraw FDA approval of bevacizumab for the treatment of metastatic breast cancer is sure to raise questions among concerned patients. Some of the answers will depend on the FDA's decision, but here's what we know now.

What did ODAC recommend?

The Oncologic Drugs Advisory Committee of the FDA recommended that bevacizumab no longer be approved for women with metastatic breast cancer. The committee voted unanimously that two new studies that were required for bevacizumab to complete the approval process (following an accelerated approval in 2008) do not "provide confirmatory evidence of clinical benefit of bevacizumab in combination with paclitaxel for the initial treatment of [metastatic breast cancers]." The committee voted 12 to 1 that "the indication for treatment of metastatic breast cancer be removed from the Avastin label."

When will the FDA make its decision?

The FDA is expected to decide later in the year whether or not to accept ODAC's recommendation.

If FDA decides to go along with ODAC, will bevacizumab still be available to patients with advanced breast cancer?

Yes. Physicians would still be able to use bevacizumab off label to treat patients with metastatic breast cancer. The use of bevacizumab off-label rather than for an FDA-approved indication, however, might affect costs and insurance coverage for bevacizumab, which could in turn limit its accessibility for patients (see page 35 for more on insurance implications).

Does the FDA's decision affect other indications for the use of bevacizumab?

No. The FDA's decision on the use of bevacizumab for metastatic breast cancer will not affect the drug's FDA-approved indications for metastatic colorectal cancer, metastatic nonsquamous non-small cell lung cancer, and metastatic renal cell carcinoma. ■