FDA Raises Questions About Benefits Of Avastin For Breast Cancer Patients

Main Category: Breast Cancer
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 20 Jul 2010 - 3:00 PDT

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Treating breast cancer with a combination of chemotherapy and the cancer drug Avastin "is not clinically meaningful," according to an FDA document published online on Friday, Dow Jones/Wall Street Journal reports. FDA said the level of improvement in women treated with chemotherapy and Avastin was not significantly better than in women who received chemotherapy alone. In addition, women who took Avastin experienced more serious side effects, such as bleeding.

The finding was released ahead of a Tuesday meeting of the agency's Oncologic Drugs Advisory Committee, which FDA has asked to consider "whether clinical benefit has been demonstrated" with Avastin use. The drug -- which is also approved to treat colon, lung, kidney and other cancers -- received "accelerated approval" in 2008 for the treatment of breast cancer in combination with the chemotherapy drug paclitaxel. Accelerated approval is granted to drugs based on initial positive studies, and drugmakers must submit additional data for full approval.

Roche Holding, Avastin's manufacturer, submitted two follow-up studies for full approval of Avastin. FDA said the follow-up research "failed to confirm the magnitude" of the benefits observed in the initial study used for accelerated approval. However, Roche maintained that the research shows Avastin is "safe and effective" when combined with chemotherapy to treat breast cancer.

Based on the committee's recommendations, FDA could withdraw Avastin's breast cancer indication or recommend full approval and allow it to be used as a combination treatment, according to the Dow Jones/Journal. A decision is expected by September (Corbett Dooren, Dow Jones/Wall Street Journal, 7/16).

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