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.