FDA to review Genentech's applicaiton of Avastin as breast cancer drug

WASHINGTON The Food and Drug Administration has determined that Avastin (bevacizumab), a Genentech drug indicated for the treatment of colorectal cancer, did not significantly help women with breast cancer live longer, the New York Times has reported.

Coming close on the heels of a pricing inquiry by Herb Kohl, D-Wis., chairman of the Senate Special Committee on Aging, the news seems to herald another headache for Genenentech.

An advisory committee to the FDA will meet Wednesday to discuss whether Avastin will win an additional approval for breast cancer. The drug had $1.7 billion in United States sales in the first nine months of the year.

The question, according to the FDA, is whether the benefits outweigh the costs. While the study showed that the overall survival rate for breast cancer patients did not significantly change with Avastin, the length of time before symptoms worsened nearly doubled when the drug was taken in combination with paclitaxel. However, the FDA is often more likely to look at overall survival, rather than what is known as progression-free survival.

In addition, as with many cancer drugs, Avastin can have serious side effects. The FDA said that 71 percent of the women who got Avastin suffered from a serious side effect, compared with 51 percent of the women who got paclitaxel alone. Among these were the deaths of at least five patients that the FDA said were probably or definitely due to the treatment itself, representing 1.4 percent of the women getting Avastin. There were no deaths from the treatment itself among women getting only paclitaxel.

FDA staff did not take a position on whether Avastin should be approved for breast cancer.