Entecavir Post-Marketing Surveillance Study To Track Cancer Risk
This article was originally published in The Pink Sheet Daily
Executive Summary
Entecavir preclinical carcinogenicity studies exhibit an increased risk of tumors in rodents. Bristol-Myers Squibb's proposed post-marketing study may not be long enough to track cancers with long latency, FDA says. Advisory committee will review entecavir for treatment of hepatitis B on March 11.
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Bristol’s Baraclude (Entecavir) Recommended For First-Line Hep B Treatment
Bristol-Myers Squibb’s Baraclude (entecavir) recommended for first-line treatment of chronic hepatitis B virus at meeting of FDA’s Antiviral Drugs Advisory Committee. The committee unanimously agrees entecavir has favorable risk/benefit profile despite potential carcinogenicity risks.
Bristol Entecavir Goes To Antiviral Advisory Committee March 11
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