FDA Advisory Committee Does Not Recommend Approval for Avastin®for Breast Cancer

FDA Advisory Committee Does Not Recommend Approval for Avastin® for Breast Cancer

The Oncology Drugs Advisory Drugs Committee (ODAC) of the United States Food and Drug Advisory (FDA) has recommended against FDA approval of Avastin® (bevacizumab) as initial therapy for metastatic breast cancer.

Metastatic breast cancer refers to cancer that has spread to distant sites in the body. Chemotherapy is a cornerstone of therapy for metastatic breast cancer; however, novel therapeutic approaches are now providing more targeted methods of treatment.

Avastin is an agent targeted against the vascular endothelial growth factor (VEGF). VEGF is involved in the growth and spread of cancer cells, which Avastin reduces or prevents. Avastin is already approved for the treatment of some colon and lung cancers and has demonstrated activity in the treatment of breast cancer.

The ODAC is a committee that makes recommendations to the FDA regarding approval of drugs for use in oncology. Although the FDA is not required to follow recommendations of the ODAC, it typically does.

The ODAC did not recommend approval of Avastin for metastatic breast cancer because the drug did not demonstrate an improvement in overall survival for this disease. Although Avastin did demonstrate an improvement in progression-free survival for metastatic breast cancer, the committee felt that the data did not warrant an approval.

The FDA will decide February 23, 2008 upon the approval of Avastin as initial therapy for metastatic breast cancer.

Reference: Genentech. Genentech Provides Update From Avastin FDA Advisory Meeting. Available at: . Accessed December 2007.

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