FDA To Review Genentech's Avastin For Use As Breast Cancer Treatment
Genentech on Thursday announced that an FDAadvisory panel in December will review its colon and lung cancertreatment Avastin as a first-line treatment for metastatic breastcancer, Reuters reports (Baertlein, Reuters, 9/13).
Genentechin May 2006 filed for FDA priority review of its application to useAvastin as a breast cancer treatment based on data from a late-stageclinical trial. The trial -- which involved 722 patients withpreviously untreated, locally recurrent or metastatic breast cancer --found that Avastin reduced the risk of disease progression or death by52% for patients who used the treatment with chemotherapy, comparedwith patients who only underwent chemotherapy.
Avastin -- which costs about $50,000 annually as a treatment for colon cancer -- might costas much as $100,000 to treat breast cancer because breast cancerpatients would require a double dose of the drug. FDA in September 2006requested that Genentech provide more thorough data than it gave in thelate-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 theapplication. FDA is expected to take action on the application by Feb.23, 2008 (Reuters, 9/13). Avastin, which is approved as abreast cancer treatment in the European Union, increasingly is beingprescribed off-label to treat breast cancer, Dow Jones reports (Gryta, Dow Jones, 9/13).
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