Posted: August 8, 2012

On December 10, 2010 the US Food and Drug Administration announced that it was withdrawing its approval for the use of Bevacizumab (Avastin®) for the treatment of metastatic breast cancer.  Was this politically motivated? Is this Obamacare run amok? Would women die who otherwise would have lived?

In response to the public’s demand for new cancer drugs, the FDA during the Bush administration devised a faster procedure for bringing new cancer drugs to market.  In 2008 it granted expedited but conditional approval for Genentech, the manufacturer of many useful cancer drugs, to sell Avastin for the treatment of advanced metastatic breast cancer. Under Congressionally mandated rules, a condition for expedited approval is the obligation of the FDA to review additional data after a couple of years to confirm or rescind its original approval.

When the Advisory Panel of the FDA reviewed updated efficacy data last year they concluded that the data did not support the use of Avastin for the treatment of advanced breast cancer.  In July they voted 12-1 to rescind the approval previously given; in December the final decision was made to uphold the recommendation of the Advisory Panel. The basis for that decision was two later clinical trials which failed to confirm that Avastin, added to best available chemotherapy, improved survival over that seen with chemotherapy alone.  In addition the impressive array of side effects of Avastin, mostly related to bleeding and wound healing, made its toxicity a source of concern.  A large recent updated analysis confirms a near doubling of treatment-related mortality in patients on Avastin, although the absolute death rate was low.

+ Read more about Avastin and Dr. Stark’s comments at the BS757 blog.