FDA Rescinds Approval of Avastin for Breast Cancer

November 21, 2011

In an expected move, the FDA has withdrawn its accelerated approval of Avastin (bevacizumab) for the treatment of breast cancer. Specifically, bevacizumab is no longer indicated for use in combination with paclitaxel for patients with HER2-negative metastatic breast cancer who have not undergone chemotherapy.

In an expected move, the FDA has withdrawn its accelerated approval of Avastin (bevacizumab) for the treatment of breast cancer. Specifically, bevacizumab is no longer indicated for use in combination with paclitaxel for patients with HER2-negative metastatic breast cancer who have not undergone chemotherapy.1 Bevacizumab’s approval for the treatment of certain types of colon, lung, kidney, and brain cancer remains in place.

Genentech, the drug’s manufacturer, is now required to remove the indication of breast cancer from the drug’s labeling, and any use of bevacizumab for breast cancer will be off-label. Medicare, however, will continue paying for the drug for the time being, despite that the yearly cost of the drug with infusion fees reportedly can reach up to $100,000. Whether CMS will eventually change its coverage policies is unknown, but many private insurance companies have already decided to not cover off-label use of this drug.

Reference
U.S. Food and Drug Administration. FDA Commissioner removes breast cancer indication from Avastin label. . Accessed November 18, 2011.

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