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FDA revokes approval of breast cancer drug

FDA.Protest.June2011.jpgIt’s finally official: the US Food and Drug Administration (FDA) has withdrawn its approval of the drug Avastin (bevacizumab) to treat advanced breast cancer. Avastin retains its approval for some other colon, kidney, and brain cancers.

The decision comes as no surprise to those watching the saga unfold since last year. In December, an advisory board voted 12-1 to recommend withdrawal of the breast cancer indication because Avastin failed to significantly improve survival, yet posed a risk of serious side effects. Genentech, which developed the drug, protested the decision in an unusual hearing held this summer. (See FDA hearing on Avastin draws protestors’.) The advisory committee stuck to its earlier decision. (See ‘Committee votes to withdraw approval for breast cancer drug’.)

Now the FDA has, as it often does, sided with its advisory committee. The decision to pull the breast cancer indication for Avastin will come as a blow to the patient advocates who protested at the FDA hearing last June (pictured). Indeed, many health care workers still believe the drug could help breast cancer patients despite evidence to the contrary. A survey of 564 health care workers published in the journal Cancer in October showed that 46.5% would still use the drug to treat some advanced breast cancers.

Photo courtesy Abigail Alliance for Better Access to Developmental Drugs


  1. Report this comment

    Gregory D. Pawelski said:

    One breast cancer patient’s life saving therapy is another’s pulmonary embolism without clinical benefit. Until such time as cancer patients are selected for therapies predicated upon their own unique biology, we will confront one Avastin after another.

    The solution to this problem is to investigate the VEGF targeting agents in each individual patient’s tissue culture, alone and in combination with other drugs, to gauge the likelihood that vascular targeting will favorably influence each patient’s outcome.

    The Avastin saga is but one example of what will occur repeatedly. The one-size-fits-all paradigm is crumbling as individual patients with unique biological features confront the results of the blunt instrument of randomized clinical trials.

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    Toxins said:

    I am actually surprised the FDA decided to halt the use of a drug. People shouldn’t fret about this but look for better alternatives. There is strong evidence that nutrition plays a major role in developing cancer and that we can prevent and in many cases, reverse breast cancer through diet. Check out this non commercial, science based website that explains.

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    Michael Lerman said:

    Avastin is the classical “smart targeted drug”; the drugging revolution prompted by the Genome sequence has failed and the hunt for more costly smart drugs should be abandoned. However “big Pharma” and NCI supported researchers are still looking for new costly smart targeted drugs (which have off-target-targets!) to which cancers quickly develop resistance and accelerate metastasis.

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