FDA To Yank Avastin Breast Cancer Approval

12/16/10

The FDA said today it is planning to rescind its approval of Genentech’s bevacizumab (Avastin) as a treatment for breast cancer. The drug, a targeted antibody drug that chokes off blood flow to tumors, is also approved for colon and lung cancer, and will remain so. The benefits of using the treatment for breast cancer has been more controversial, particularly since July, when an FDA advisory panel voted 12-1 in favor of withdrawing the breast cancer approval, as noted today by Andrew Pollack of the New York Times. Genentech, a unit of Switzerland-based Roche, plans to request a hearing to appeal the decision, the company said in a statement.

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  • http://www.dailygrommet.com Jules Pieri, CEO Daily Grommet

    Hold on Luke….I need to know more. My mom is undergoing treatment for colon cancer via Avastin. What is the issue?

  • http://www.xconomy.com/author/ltimmerman/ Luke Timmerman

    Jules–there’s no issue here for use of Avastin in treating colon cancer. The drug was first FDA approved for colon cancer in 2004, and the additional approval of Avastin for breast cancer came in 2008. Skeptics on an advisory panel thought the proof of benefit in breast cancer was thin more than 2 years ago, and, as usual, they wanted to see more results from clinical trials. As NYT’s Andy Pollack notes, when more data from breast cancer patients on Avastin came out, it showed “Avastin did not prolong lives and delayed the worsening of the cancer by only one to three months, while increasing side effects.” An F.D.A. advisory committee voted 13-0 in July that the new studies did not confirm the benefit of the drug. So it’s no big surprise that the FDA is now officially taking steps to revoke the breast cancer approval. It could cost Roche a lot of sales, maybe $500 million a year, but then again, maybe not that much. The drug is currently approved for colon and lung cancer, and oncologists are free to prescribe Avastin “off-label” for breast cancer if they choose. They might have to jump through more red tape with insurers to justify why they wrote the prescription, if they want to get reimbursed.