The FDA isn't impressed with Avastin's results against breast cancer. Up for vote by an advisory committee tomorrow, the Genentech drug didn't extend women's lives significantly, the agency said in its pre-meeting review of the drug. And it caused troubling side effects, too. Already a top-selling drug for colon and non-small cell lung cancer, Avastin did delay metastasis. That benefit has to be weighed against the risk of severe side effects, including death, the FDA said
The agency fell short of recommending against approval of the drug for breast cancer use. And its negative review doesn't mean that the advisory panel will vote Avastin down; as the New York Times notes, doctors on the committee may "look more kindly" on the drug than FDA staff does, because it's the staff's role to point out flaws in the data. But the stock market took a pessimistic view. Genentech stock fell by 3.6 percent on news of the FDA staff's report.
Avastin re-submitted to FDA. Report
Avastin encounters rare failure for pancreatic cancer. Report
Genentech touts pipeline prospects as doubts fester. Report