Avastin OK'd for Advanced Breast Cancer
FDA Approves Avastin for Certain Patients With Advanced Metastatic Breast Cancer
Feb. 22, 2008 -- The FDA today approved the drug Avastin for use with chemotherapy for certain cases of advanced breast cancer.
Avastin may be used in combination with the chemotherapy drug Taxol in patients who haven't had chemotherapy and who have metastatic HER2-negative breast cancer.
HER2 is a protein found in high levels in tumors that are HER2-positive. Most breast cancers are HER2-negative.
Avastin isn't a new drug. It is already used to treat metastatic colorectal cancer and a certain type of advanced lung cancer (advanced non-squamous, non-small-cell lung cancer).
Last December, an FDA advisory panel recommended against approving Avastin's use with Taxol for metastatic breast cancer. The panel found that the drug combination slows the spread of metastatic breast cancer but doesn't improve overall survival.
The FDA, which isn't obligated to follow the advice of its advisory panels, granted "accelerated approval" for Avastin's use in treating advanced breast cancer.
Accelerated approval is given "to make promising products for life-threatening diseases available on the market on the basis of preliminary evidence prior to formal demonstration of patient benefit," states the FDA's web site.
Genentech, the company that makes Avastin, must submit additional data to the FDA to convert the accelerated approval to full approval.