Food
and Drug Administration
Center for Drug Evaluation and Research (CDER)
Antiviral Drugs Advisory Committee
FINAL
QUESTIONS
Question 1:
How would you assess the risk-benefit of ETV in the context of the
available clinical safety, efficacy, resistance, and non-clinical
carcinogenicity data?
Question 2:
A.
Does the
risk-benefit assessment for entecavir support the approval of entecavir for the
treatment of chronic HBV in adult patients?
B.
If the
answer to #2A is no, what information would be needed to support a
resubmission?
Question 3:
A.
If the
answer to #2A is yes, discuss whether the results of the rodent carcinogenicity
studies should impact the Indication and Usage section of product labeling.
B.
Based on the
available data, discuss the potential role of entecavir in the HBV treatment
armamentarium.
Question 4:
A.
Assess the
potential risks and benefits of proceeding with development of entecavir for
the treatment of chronic HBV in pediatric patients.
B.
What, if
any, additional information is needed in order to proceed?
Question 5:
Discuss the applicant’s proposed pharmacovigilance plan to address
human cancer risk, including comments on the design of the proposed large
simple study.
Question 6
Are there other issues that you would like to see addressed through
post-marketing commitments?