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

Main Category: Breast Cancer
Also Included In: Regulatory Affairs / Drug Approvals;  Women's Health / Gynecology
Article Date: 19 Sep 2007 - 7:00 PDT

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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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