FDA Rejection Of Avastin For Breast Cancer Therapy Would Be 'Unscientific, Unethical,' Editorial Says

Main Category: Breast Cancer
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 22 Feb 2008 - 12:00 PDT

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It would "not only be unscientific but unethical" for FDA to reject Genentech's colon and lung cancer treatment Avastin for use as metastatic breast cancer treatment, a Wall Street Journal editorial says (Wall Street Journal, 2/21).

FDA is scheduled to decide Saturday whether to approve Avastin for treatment of metastatic breast cancer. Genentech in May 2006 filed for FDA priority review of its application based on data from a previous late-stage clinical trial. The trial 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. FDA's Oncologic Drugs Advisory Committee in December 2007 voted 5-4 against recommending that the agency approve the application. The panel based its decision on a separate study that found the drug's effectiveness in slowing the progression of the disease did not outweigh its toxic side effects. Genentech's application could be bolstered by the results of a recent clinical trial that found Avastin prolonged progression-free survival when combined with chemotherapy, but the study has not been running long enough to determine if the drug lengthens lives (Daily Women's Health Policy Report, 2/14).

According to the Journal, it is "not as though the panel or the larger FDA bureaucracy don't recognize or acknowledge Avastin's real benefits." Rather, FDA's "lords of medicine may conclude that those benefits don't matter" because they "don't fall into the categories that the FDA generally uses to evaluate the safety and efficacy of a drug," the editorial says. In only a "few isolated contemporary cases" has FDA deemed progression-free survival as a relevant "end point" for approval, the Journal says, adding that there is "no other reason" Genentech's application would not be approved than the agency's "obsolete, even anti-modern, regulations and approval models."

According to the Journal, thousands of breast cancer patients, on the advice from their oncologists, are taking Avastin "off label." An adverse FDA ruling will make it "far more difficult for them to do so," the editorial says, concluding that it "would also be the latest moral indictment of everything that's wrong with the FDA" (Wall Street Journal, 2/21).

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