FDA Panel Recommends Against Avastin For Breast Cancer Treatment

Main Category: Breast Cancer
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 22 Jul 2010 - 3:00 PDT

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On Tuesday, the FDA Oncologic Drugs Advisory Committee voted 12-1 to recommend that the agency revoke approval of Avastin for the treatment of breast cancer, citing sparse evidence that the drug benefited patients in two new studies, the New York Times reports (Pollack, New York Times, 7/20).

FDA still needs to make a final decision about whether to revoke Avastin's breast cancer indication, though the agency typically follows its advisory panels' advice. FDA's decision would not affect the drug's approval status for other indications, including brain, colon, kidney and lung cancers. A final ruling is expected by Sept. 17. Avastin -- manufactured by Roche's Genentech unit -- had worldwide sales of $6 billion in 2009 (Corbett Dooren, Wall Street Journal, 7/20).

In 2008, FDA granted Avastin accelerated approval, which allows the agency to approve treatments for life-threatening conditions based on limited proof of effectiveness. Companies must then conduct follow-up studies to validate the initial data and obtain full approval (New York Times, 7/20). The 2008 approval allowed Roche to market Avastin for use in combination with chemotherapy to treat the most common form of advanced breast cancer.

A preliminary study used for the accelerated approval showed that Avastin increased progression-free breast cancer survival by 5.5 months when combined with the chemotherapy treatment paclitaxel. However, two more recent studies found that Avastin had a more modest effect on progression-free survival, extending progression-free survival by less than one month to 2.9 months and showing no effect on overall survival. The new studies also showed that patients who received Avastin experienced more severe side effects (Wall Street Journal, 7/20). The side effects included bleeding, blood clots and gastrointestinal perforations (Richwine, Reuters, 7/20).

According to the Journal, the panel unanimously concluded that the follow-up studies failed to confirm Avastin's clinical benefit (Wall Street Journal, 7/20). The new information shows "there's very little benefit to patients -- with significant toxicity risks and no clear survival benefit," Natalie Compagni Portis, the panel's patient representative, said (Perrone, AP/Atlanta Journal-Constitution, 7/20).

Genentech said in a statement that "Avastin should be an option for patients with this incurable disease" (Wall Street Journal, 7/20).

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