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.