The use of Avastin for various cancers is being addressed by the U.S. Food and Drug Administration this week and while many women are aware that it’s an emotional battle, not everyone understands why.
In 2008, Avastin was given preliminary approval by the FDA for the treatment of breast cancer on the condition that the company would do more studies to demonstrate its effectiveness. Many women have been successfully treated with Avastin -- a billion dollar drug for Roche, the manufacturer.
But when Roche submitted the required follow-up studies in 2010, the data showed that there was no benefit from the drug for treating breast cancer. In addition, the drug was associated with some significant side effects such as high blood pressure and blood clots.
In December, 2010, an FDA panel voted to withdraw the drug's approval as a treatment for breast cancer. Roche appealed the decision. Earlier this week, an FDA panel hearing the appeal unanimously decided, in a 6-0 vote, to withdraw the drug's indication for breast cancer. The final decision on whether or not Avastin loses its indication for breast cancer is ultimately up to the FDA Commissioner, Dr. Margaret Hamburg.
If Hamburg revokes Avastin's indication for breast cancer, it will be a landmark decision for the FDA and, at the same time, will fuel significant emotion among patients. Here's why:
• From the FDA’s side: The FDA issued a provisional approval with the explicit understanding that the final decision would be based on more conclusive studies. If the FDA maintains the drug's approval despite the lack of scientific data, this would likely impact all of their future decisions to offer provisional approvals for potentially life-saving drugs.
• From the patients' side: Women who have benefited from the medication have clearly voiced their opinion that the doctors and patients, not regulators, should decide whether or not to get potentially life-saving treatment.
An important fact to keep in mind is that Avastin will remain on the market because it is FDA-approved for certain types of lung, colon, kidney and brain cancers. Therefore, Avastin will still be available "off label" for treating breast cancer. The challenge will be getting the medication paid for by insurance since use of expensive drugs "off-label" are frequently not a covered benefit. Avastin costs well over $80,000 per year.
Sources:
FDA begins process to remove breast cancer indication from Avastin label
www.fda.gov/newsevents/newsroom/pressannouncements/ucm237172.htm
Breast Cancer Patients Protest FDA Hearing On Avastin Drug
http://wamu.org/news/11/06/28/breast_cancer_patients_protest_fda_hearing_on_avastin_drug.php
FDA panel: Avastin not effective for breast cancer
http://www.msnbc.msn.com/id/43581639/ns/health-cancer/
Reviewed July 1, 2011
by Michele Blacksberg R.N.
Edited by Alison Stanton