• 21
  • November
    2011

FDA Commissioner Margaret Hamburg's 69-page decision, as Rob Stein reports for the Washington Post, clearly indicates the FDA's position that breast cancer drug Avastin was "harming more women" than it helped.

As often happens when it comes to pharmaceutical drugs, there are many industry players involved, from the FDA to oncologists to policymakers. It's not clear yet whether medical malpractice played a role in adverse patient outcomes - though it often seems to, given that doctors involved in drug safety studies often seem to be on drug makers' payrolls.

That might not be the case with Avastin.

But we now know that Hamburg has followed the unanimous recommendation of an FDA advisory panel to revoke FDA approval of the breast cancer drug - citing the disappointing results of "rigorous testing."

She said, "Despite the hopes of investigators, patients, industry, and even the FDA itself, the results of rigorous testing can be disappointing. This is the case with Avastin when used for the treatment of metastatic breast cancer," as Stein reports.

Avastin will remain on the market for treatment of other types of health conditions, just not metastatic breast cancer. But insurers have begun to stop paying for Avastin, which may mean the end of widespread use of the drug.

Source: The Washington Post, "FDA revokes Avastin's approval for breast cancer treatment," by Rob Stein, 11/18/11