On the FDA’s Decision To Withdraw Avastin’s Breast Cancer Indication

Merrill Goozer

Posted 11/18/11 on Gooz News

They did the right thing. Two clinical trials showed no improvement in mortality among women with metastatic breast cancer. Those trials didn’t even replicate the delay in progression of disease that had been shown in the original trial that led to accelerated approval in 2007.

Now comes the firestorm from patient advocacy groups, who will use anecdotal stories to claim the drug works for some women. The drug industry’s flaks and sycophants will suggest the FDA’s overweaning regulatory apparatus is stifling innovation.

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