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On November 18, 2011, the New York Times published an article referencing the F.D.A.’s recent decision to revoke the drug Avastin as a treatment option for breast cancer patients. This decision came after a two-day hearing held in June of this year. Findings from clinical trials on Avastin showed that the drug did not have positive effects, such as prolonging a patient’s life or providing control for tumors. Rather, these clinical trials showed that the drug has the potential of producing serious side effects, such as hemorrhaging and high blood pressure.
Avastin is used to treat different types of cancer, and was approved by the F.D.A. in 2008 to treat metastatic breast cancer. The drug will remain on the market for the treatment of these other types of cancer. Although the drug will remain on the market, it is possible that insurance companies will no longer cover Avastin for the treatment of breast cancer patients. Without insurance coverage, the drug costs roughly $80,000 per year for a patient.
The drug was approved by the F.D.A. under the accelerated program, a system that permits the approval of drugs without the customary evidence of effectiveness deemed necessary by the agency. The efficacy of the drug is tested after its approval, through clinical trials or follow-up studies. The F.D.A. has been criticized in the past for failing to carry out these subsequent clinical trials. Avastin is one of the few cases where the F.D.A. has revoked its previous approval of a drug after conducting clinical trials to measure its efficacy. In doing so, the agency showed that the approval of a drug could be reversed if the evidence shows it does not provide effective treatment.
See the full New York Times article at:
http://www.nytimes.com/2011/11/19/business/fda-revokes-approval-of-avastin-as-breast-cancer-drug.html?_r=1&pagewanted=print
See the F.D.A.’s report regarding the withdrawal of approval for Avastin:
http://www.fda.gov/downloads/NewsEvents/Newsroom/UCM280546.pdf
See the F.D.A.’s news release regarding the Avastin decision:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm280536.htm
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