As Expected: Thumbs Down for Genentech's Avastin
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The NY Times reported today that a federal advisory committee voted that Genentech’s drug Avastin should not be approved as a treatment for metastatic breast cancer.
By a 5-4 vote, the committee decided that Avastin’s ability to delay the worsening of cancer did not outweigh the drug’s toxic side effects, especially since women getting Avastin did not live significantly longer in the end. Although the committee recommended against approval for Avastin, FDA has the final word. That said, FDA usually follows the recommendations of its external advisory panels.
FDA’s staff reviewers had been critical of the drug in an analysis released on Monday. Nevertheless, many Wall Street analysts thought the committee, made up mainly of cancer experts and physicians, would vote in favor of approval.
Analysts were expecting an approval in breast cancer to add $1 billion or more to annual sales of Avastin. Genentech’s stock price has been steadily declining for the last two years because its once explosive growth appears to be slowing.
Avastin is already one of the world’s best-selling cancer drugs, with United States sales alone of $1.7 billion in the first nine months of 2007.
Until next time....
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