FDA Grants Accelerated Approval Of Avastin For Late-Stage Breast Cancer

Main Category: Breast Cancer
Article Date: 27 Feb 2008 - 6:00 PDT

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FDA granted accelerated approval to Genentech's cancer treatment Avastin for metastatic breast cancer treatment Friday despite an agency advisory panel recommendation against approval of the drug for that purpose, the AP/Philadelphia Inquirer reports (Perrone, AP/Philadelphia Inquirer, 2/23). Accelerated approval is used for drugs that treat life-threatening diseases and allows treatments to reach the market with "less than ideal data, subject to future study," according to the New York Times (Pollack, New York Times, 2/23). The accelerated approval status means that Genentech can market and sell the drug to breast cancer patients but must submit the results of two pending studies to receive full approval (Chase/Wilde Mathews, Wall Street Journal, 2/23).

According to the Times, the decision has been "closely watched as a harbinger" of FDA's requirements for cancer drugs. The "big question" was whether the agency thought that slowing a tumor's growth without increasing life expectancy was "enough" for the agency to approve Avastin, the Times reports (New York Times, 2/23).

Avastin works by limiting blood to tumors (Newark Star-Ledger, 2/25) and is currently approved to treat colon and lung cancer and is in clinical trials for more than 20 tumor types (Morrill, Contra Costa Times, 2/23). FDA's Oncologic Drugs Advisory Committee, which in December 2007 had voted 5-4 against recommending that the agency approve the application, based its decision on a study that found that the drug's effectiveness in slowing the progression of the disease did not outweigh its toxic side effects (Daily Women's Health Policy Report, 2/21). Side effects of the drug include bleeding, heart attack, stroke and other complications (Colliver, San Francisco Chronicle, 2/23). According to the Times, about five or six of the 363 patients in a study died as a result of taking Avastin (New York Times, 2/23).

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Richard Pazdur, who oversees cancer treatments at FDA, said that the decision does not represent a shift in FDA's standards for evaluating drugs and noted that the agency still prefers increased survival as the standard for drug approval. However, Pazdur said, "We wanted to have the regulatory flexibility to approve effective drugs where there isn't overall survival," adding that delaying the progression of life-threatening tumors might "be a direct clinical benefit in itself" (New York Times, 2/23).

David Schenkein, senior vice president and head of oncology at Genentech, said, "Metastatic breast cancer is a disease we cannot cure at this time," adding, "What this FDA approval does is give women another option that ... we believe is very important for women with advanced-stage breast cancer" (San Francisco Chronicle, 2/23). Pazdur and Schenkein said that it is undecided whether increasing survival time will be necessary for the drug to be granted full approval (New York Times, 2/23).

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