Genentech's Avastin Effective At Treating Breast Cancer, Study Says

Main Category: Breast Cancer
Article Date: 15 Feb 2008 - 8:00 PST

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FDA will decide on Feb. 23 whether to approve Genentech's colon and lung cancer treatment Avastin for treatment of metastatic breast cancer, the Wall Street Journal reports (Chase, Wall Street Journal, 2/13). Genentech's application could be bolstered by the results of a second clinical trial conducted by Roche -- a majority shareholder of Genentech that markets the drug internationally -- which the company says shows it was effective in treating the disease -- the New York Times reports. For the study, 736 women received a separate chemotherapy drug, docetaxel, in combination with Avastin or a placebo. The study tested Avastin as an initial treatment for women whose breast cancer had recurred or spread beyond their breasts. The study found Avastin prolonged progression-free survival when combined with chemotherapy in a breast cancer study, but the study has not been running long enough to determine if the drug lengthens lives. Genentech did not provide any numerical results but said they would be presented at a medical meeting in the coming months (Pollack, New York Times, 2/13).

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 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 (Daily Women's Health Policy Report, 9/17/07). FDA's Oncologic Drugs Advisory Committee in December 2007 voted 5-4 against recommending that the agency approve marketing for the drug, the Times reports. The advisory 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 (New York Times, 2/13).

Genentech in a statement said it believes that the results of the new study "provide confirmation of Avastin's efficacy and safety in this patient population" (New York Times, 2/13). Hal Barron, Genentech's chief medical officer in a statement said, "We are pleased that a second Phase III study in this population of breast cancer patients showed a significant improvement in progression-free survival." He added, "The trial also demonstrated Avastin's potential with a different chemotherapy in this disease" (Berkrot, Reuters, 2/12).

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