FDA Requests More Data On Avastin's Use To Treat Breast Cancer; Approval Could Be Delayed One Year, Company Says

Pharmaceutical company Genentech on Monday said FDA has asked it to submit more data in its application to use the colorectal cancer medication Avastin as a treatment for breast cancer, the Wall Street Journal reports (Loftus, Wall Street Journal, 9/12). Genentech in May filed for FDA priority review of its Avastin application based on data from a late-stage clinical trial. The trial -- which involved 722 patients with previously untreated, locally recurrent or metastatic breast cancer -- finds that Avastin reduced by 52% the risk of disease progression or death 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 -- will cost as much as $100,000 to treat breast cancer because breast cancer patients would require a double dose of the drug (Kaiser Daily Women's Health Policy Report, 5/30). According to the New York Times, FDA was expected to approve the application by November. Genentech said FDA is requesting that the company 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. The company said it could provide the data FDA requested by the middle of 2007, and analysts said the earliest FDA could approve the drug is late 2007. FDA said it would not comment on the drug because it is under review (Pollack, New York Times, 9/12). Hal Barron, senior vice president of development for the company, in the release said, "We are disappointed that this will cause a delay in the review of our application, as there is a great unmet medical need for women with metastatic breast cancer" (Wall Street Journal, 9/12).


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