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Entecavir Should be Labeled for First Line Therapy in Chronic Hepatitis B Despite Cancer Risks
Mar 12, 2005, 07:20, Reviewed by: Dr.
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�I agree with what has been said that it doesn�t 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,
Bristol-Myers Squibb�s Baraclude (entecavir) should be indicated for first-line use in the treatment of chronic hepatitis B infection despite potential carcinogenic risks, FDA�s 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 doesn�t 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 agency�s question of whether rodent carcinogenicity studies exhibiting tumor growth at maximum tolerated doses should impact the product�s indication.
Weighing the HBV therapy�s 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.
�I�ve heard quite universal opinion that there is a favorable risk/benefit for the drug entecavir,� committee chair Janet Englund (Children�s 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 doesn�t 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. 
- FDA Advisory Committee
FDA Advisory Committee
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