The US Food and Drug Administration (FDA) today announced it was stripping the drug Avastin for approval for use to treat breast cancer. The move comes four months after an advisory committee of the FDA agreed that Avastin approved for breast cancer in 08, does not allow the disease after all.
Today's announcement by FDA Commissioner Margaret Hamburg, is not really a surprise. In part, this is because the FDA usually follows the recommendations of its advisory committees. But high audience June issues, FDA officials have also argued that the cancellation of approval of Avastin for breast cancer was the right thing to do. The drug was approved as part of a "fast-track" program to the FDA, which aims to get medicines more quickly to those in need. But it also means therapies are approved with clinical data less under their belt, and was the case with Avastin. FDA gave its blessing on the basis of a test showing that it offered breast cancer patients an extra 5.5 months of "progression free survival" as their tumors are not growing. Subsequent tests showed a more modest benefit, in one case, less than a month, and the drug has serious side effects.
Avastin will remain on the market for several other cancers.
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