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5 December 2013 11:26 am ,
Vol. 342 ,
Snake venoms are remarkably complex mixtures that can stun or kill prey within minutes. But more and more researchers...
At age 30, Dutch biologist Freek Vonk has built up a respectable career as a snake scientist. But in his home country,...
Since arriving on the island of Guam in the 1940s, the brown tree snake ( Boiga irregularis ) has extirpated native...
An animal rights group known as the Nonhuman Rights Project filed lawsuits in three New York courts this week in an...
Researchers have been hot on the trail of the elusive Denisovans, a type of ancient human known only by their DNA and...
Thousands of scientists in the Russian Academy of Sciences (RAS) are about to lose their jobs as a result of the...
Dyslexia, a learning disability that hinders reading, hasn't been associated with deficits in vision, hearing, or...
Exotic, elusive, and dangerous, snakes have fascinated humankind for millennia. They can be hard to find, yet their...
- 5 December 2013 11:26 am , Vol. 342 , #6163
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FDA Pulls Avastin for Breast Cancer
18 November 2011 12:48 pm
The U.S. Food and Drug Administration (FDA) announced today that it was stripping the drug Avastin of its approval for use to treat breast cancer. The move comes 4 months after an FDA advisory committee agreed that Avastin, approved for breast cancer in 2008, doesn't help that disease after all.
Today's announcement, by FDA Commissioner Margaret Hamburg, isn't much of a surprise. In part, that's because FDA usually follows its advisory committees' recommendations. But at a high-stakes June hearing, FDA officials had also argued that rescinding Avastin's approval for breast cancer was the right thing to do. The drug was approved under a "fast-track" program at FDA, which aims to get drugs out more quickly to people who need them. But it also means therapies are approved with less clinical data under their belt, and that was the case with Avastin. FDA gave its blessing based on a trial showing it offered breast cancer patients an extra 5.5 months of "progression-free survival," time when their tumors weren't growing. Subsequent trials showed a more modest benefit, in one case of less than a month, and the drug has serious side effects.
Avastin will remain on the market for several other cancers.