WASHINGTON (AP) - The Food and Drug Administration is going against the recommendations of its advisory panel -- and approving a drug made by Genentech to treat breast cancer.
Advocates for breast cancer patients applauded the ruling, which could represent a major shift in the standards for judging how effective cancer medicines are.
Normally, the FDA doesn't approve a drug for late-stage cancer treatment unless there's data showing that the drug extends patients' lives or improves the quality of those lives. The company's application said Avastin didn't do either of those things; instead, the company showed that the drug slowed tumor growth, without actually increasing life expectancy.
Wall Street analysts believe the decision opens the door for other cancer drugs to be approved for their tumor-shrinking abilities. And that worries some health experts. A researcher at Johns Hopkins says the FDA may no longer see survival as the most important goal.
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