FDA OKs Avastin for Advanced Breast Cancer

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An expert panel of advisers to the FDA voted 5-4 last December not to recommend approval because the drug's ability to slow the growth of tumors did not outweigh the increased risk of blood clots and other cardiovascular troubles among users. In rare cases, patients taking Avastin with standard chemotherapy have died.

"Everybody wants to offer metastatic breast cancer patients hope, but we shouldn't offer them false hope," panel member Natalie Compagni-Portis, a patient representative with Breast Cancer Action in San Francisco, said during the December meeting, according to the Associated Press. "We have to raise the bar in terms of safety."

"These patients are terminal, and it's our job to make their lives better, not to say that it's OK to have a stroke or that it's manageable," advisory panel chairwoman Maha Hussain, an oncologist at the University of Michigan, said during the meeting. "You didn't show that patients are living better or that they're living longer."

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In trial results submitted to the FDA by Genentech before the advisory panel met, the use of Avastin (bevacizumab) did boost the progression-free survival of women with advanced breast cancer by an average of 5.5 months, when combined with paclitaxel. Progression-free survival refers to survival without any advancement of the malignancy.

However, the same study of 722 patients showed that patients reaped no gain in overall survival after taking Avastin.

Avastin is not traditional chemotherapy, but instead is a monoclonal antibody that robs tumors of their blood supply. It has been found to boost the survival of patients with metastatic colorectal cancer and non-small-cell lung cancer when added to chemotherapy and used as a first-line treatment.

According to Bloomberg News, Avastin is currently being tested against 20 cancers in 300 trials. This latest approval is expected to add more than $700 million in annual sales to the $2.3 billion in sales that was generated in 2007 by the drug's use among lung and colon cancer patients.

More information

Find out more about breast cancer and its treatment at the American Cancer Society.

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