Kathy Stewart, wtop.com
SILVER SPRING, Md. - The Food and Drug Administration will be holding a new round of hearings on using the drug Avastin for treating advanced breast cancer, and a rally has been planned by the drug's supporters.
In 2008, the FDA granted accelerated approval for Avastin to be used for late stage breast cancer overriding an FDA advisory committee which rejected the drug maker Genentech's appliaction for this use.
And three clinical trials later, the FDA now will decide if it will pull the drug from being used for this purpose. The FDA has granted the drug maker Genentech an appeales hearing set for June 28 to 29.
Breast cancer patients and families are expected to protest outside the FDA's White Oak campus, where the hearing will be held. They're hoping the FDA will not withdraw the drug for the treatment of late-stage breast cancer.
Dr. Frederick Tucker, an Oncologist in Fredericksburg, says simply that the drug did not work as it was supposed to.
"The addition of Avastin did not make patients any worse," he says. "So patients didn't live longer or better on the drug."
Besides the question of the drug's efficacy, there is concern over the drug's side-effects and its toxicity.
The National Comprehensive Cancer Network is strongly against the FDA's decision to revoke the drug. The NCCN is a not-for-profit alliance of 21 of the leading cancer centers, like Memorial Sloan-Kettering Cancer Center in New York, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Baltimore and the Fox Chase Cancer Center in Philadelphia.
Avastin has been on the market for seven years. It's been combined with other drugs and is effective in treating, but not curing, colon and lung cancers.
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