FDA Advisory Committee To Review Genentech's Avastin For Use As Breast Cancer Treatment

Genentech on Thursday announced that an FDA advisory panel in December will review its colon and lung cancer treatment Avastin as a first-line treatment for metastatic breast cancer, Reuters reports (Baertlein, Reuters, 9/13).

Genentech in May 2006 filed for FDA priority review of its application to use Avastin as a breast cancer treatment based on data from a late-stage clinical trial. The trial -- which involved 722 patients with previously untreated, locally recurrent or metastatic breast cancer -- found that Avastin reduced the risk of disease progression or death by 52% for patients who used the treatment with chemotherapy, compared with patients who only underwent chemotherapy.

Avastin -- which costs about $50,000 annually as a treatment for colon cancer -- might cost as much as $100,000 to treat breast cancer because breast cancer patients would require a double dose of the drug. FDA in September 2006 requested that Genentech provide more thorough data than it gave in the late-stage trial -- which was organized by National Cancer Institute researchers -- as well as require radiologists not involved in the trial to determine when patients' cancer has worsened (Kaiser Daily Women's Health Policy Report, 9/12/06).

According to Reuters, FDA's Oncologic Drugs Advisory Committee in December will consider the application. FDA is expected to take action on the application by Feb. 23, 2008 (Reuters, 9/13). Avastin, which is approved as a breast cancer treatment in the European Union, increasingly is being prescribed off-label to treat breast cancer, Dow Jones reports (Gryta, Dow Jones, 9/13).

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