June 29, 2011

FDA To Unendorse Biotech Drug Avastin for Metastatic Breast Cancer

The FDA voted 6-0 to remove its endorsement of the use of Avastin, a monoclonal antibody designed to target proteins which increase the blood supply to cancer cells, for use in advanced breast cancer. Reports in 2008 had indicated that the addition of this drug to a traditional chemotherapy regime could increase survival by an average of 5.5 months.  Later clinical studies did not support this optimistic view, showing a minimal effect on survival. In December, the FDA had signaled that it would begin the removal process, citing the lack of evidence to support the use of this therapeutic for this clinical indication. The manufacturer, Genentech, then took an aggressive response in the form of a petition to the FDA for a hearing on the proposed withdrawal.  In addition, patients began petitioning the FDA ro keep Avastin's approval. After a contentious hearing, the FDA panel then voted to remove the approval of Avastin for metastatic breast cancer. Of course, this has tremendous implications for patients (the cost of the drug can be around $100,000 per year) who lose viable insurance claims, as well as for the company, which can not advertise the use of this drug for this purpose.  Off-label prescribing can continue, but this whole episode is not only unnerving for the actual patients, some of whom have claimed significant benefit, but as a reminder that recently-developed biotech drugs are not legacy products, with an established risk and benefit profile. The field is obviously scientifically dynamic, but here we see the regulatory instability that attends to quickly shifting science.

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