LATE-BREAKING NEWS: FDA revokes Avastin breast cancer indication

The FDA today revoked its approval of the breast cancer indication for Avastin (bevacizumab). The drug, an anti-angiogenic therapy that blocks the vascular endothelial growth factor (VEGF) protein to prevent the growth of new tumor-nourishing blood vessels, will remain on the market as an approved treatment for metastatic colorectal cancer, non-small cell lung cancer, glioblastoma, and metastatic renal cell carcinoma (www.avastin.com).

The decision involves Avastin's use in combination with paclitaxel for patients with metastatic HER2-negative breast cancer who had not been treated with chemotherapy previously. After the accelerated approval of Avastin in February 2008 based on promising results from one study, Genentech, the drug's sponsor, completed two additional clinical trials and submitted the data to the FDA. The data did not demonstrate a sufficient effect against tumor growth compared with standard chemotherapy alone to outweigh the risks of Avastin use, which include severe hypertension, bleeding and hemorrhaging, heart attack or heart failure, and the development of perforations in the nose, stomach, intestines, or other parts of the body.

FDA Commissioner Margaret A. Hamburg, MD, based her decision to revoke the breast cancer indication for Avastin on an extensive record that includes thousands of pages submitted to a public docket, data from several clinical trials, and the record from a 2-day hearing held in June 2011.

In a statement issued by the FDA, Hamburg explained that although the decision was difficult, the evidence did not support that use of the drug would help patients live longer or improve their quality of life. “After reviewing the available studies, it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay of tumor growth, that would justify those risks” (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm280536.htm).

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