Entecavir Should be Labeled for First Line Therapy in Chronic Hepatitis B Despite Cancer Risks
Mar 12, 2005 - 7:20:00 AM
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I agree with what has been said that it doesnt really rise to a level of boxed warning, FDA Division of Antiviral Drug Products Director Debra Birnkrant said.
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By Akanksha, Pharmacology Correspondent,
[RxPG] Bristol-Myers Squibbs Baraclude (entecavir) should be indicated for first-line use in the treatment of chronic hepatitis B infection despite potential carcinogenic risks, FDAs Antiviral Drugs Advisory Committee said.
I think that the drug should be labeled for first line therapy, and I think that it will be an important addition for the treatment of those patients, committee member Kenneth Sherman (University of Cincinnati) said at the March 11 meeting.
This should be a first-line treatment. I think in most viral diseases
we try to use the most effective therapy if that doesnt result in resistance and this seems to be the case right now for entecavir, committee member John Gerber (Colorado Health Sciences Center) said.
The unanimous decision to recommend first-line use came in response to the agencys question of whether rodent carcinogenicity studies exhibiting tumor growth at maximum tolerated doses should impact the products indication.
Weighing the HBV therapys potential risk of carcinogenicity against demonstrated superior efficacy and similar safety compared to lamivudine (GlaxoSmithKline's Epivir-HBV), the committee unanimously recommended approval of the drug.
Ive heard quite universal opinion that there is a favorable risk/benefit for the drug entecavir, committee chair Janet Englund (Childrens Hospital, Seattle, Wash.) said in summarizing the sense of the committee.
The committee did not find the potential risk of tumor growth significant enough to warrant a black box warning.
I agree with what has been said that it doesnt really rise to a level of boxed warning, FDA Division of Antiviral Drug Products Director Debra Birnkrant said.
Bristol has proposed a post-marketing randomized study in 12,500 patients to detect longer-term cancer risk in patients taking Baraclude.
While the committee was unanimous in its support for the long-term trial, there was disagreement whether the trial should be randomized or observational.
I think that a randomized study design is the right way to do it and is probably the best study design, committee member Richard Haubrich (University of California, San Diego) said.
Although we think about randomized trials being the gold standard in this kind of situation, I would encourage the sponsor to think creatively about admittedly observational studies, committee consultant Beth Bell (Centers for Disease Control & Prevention) said.
While the agency supports the development of the post-marketing study, it recognizes that there are inherent limitations in a study of this type, FDA said in briefing documents for the committee.
Limitations include the possibility that the trial will be of insufficient duration to detect certain cancers.
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