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Avastin Rejection Supported by Cancer Experts
Date:7/4/2011

drug. To date, any benefit from the drug has been based on anecdotal reports.

"But in the meantime, we do not believe Avastin should retain its approval on the hope we will eventually learn there are some women who do benefit from this treatment," Jaggar said. "We can't keep drugs on the market while we wait to see if they are effective."

Dr. Marc E. Lippman, deputy director of the Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine, said he, too, supported the panel's decision. "I think they did a wise thing," he said.

But Lippman added that women should not stop taking Avastin based on the panel's recommendation. "I wouldn't, in my right mind, recommend discontinuing the drug from someone who is currently benefiting. It would be insane to stop the drug," he said.

And Klein said: "To women who are currently on the drug with advanced disease [and] doing well, you'd have to comfort them that there is a very good possibility that they will continue to do just as well with chemotherapy alone, if Avastin is no longer available. There is certainly a possibility of that."

In each trial of Avastin reviewed by the advisory panel, women who took the drug were also receiving chemotherapy, so it wasn't clear whether it was Avastin or the chemotherapy that was preventing their cancer from progressing. The trials also showed no benefit from the drug in extending life, despite the risk of serious side effects, including death.

"The gold standard has always been overall survival," Klein said. "This is one of the few drugs that was granted accelerated approval based on progression-free survival."

The hope was that studies would show the drug could extend overall survival, not just progression-free survival, Klein added, "but they failed to do it."

The advisory panel's decision now goes to FDA Commissioner Margaret Hamburg, who won't address the issue until the period for public comment ends Jul
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