On February 8, 2012, the Oncologic Drugs Advisory Committee will meet to discuss supplemental biologics license application 125320/28 for Xgeva (denosumab), submitted by Amgen (AMGN). We conducted a behavioral analysis of the voters listed on the draft committee roster to provide insight into how this panel might vote based on their past voting records. For more information on how we analyze voting behavior, please read our adcom behavioral analysis.
Of the 13 voting members listed on the draft roster, 10 members have served on 1 or more committees in which the vote was non-unanimous. Non-unanimous votes provide the differential voting patterns that allow us to analyze voter behavior. A summary of the voting records for these 10 individuals is listed in the table below. Please click each name for a detailed voting history.
The average liberal-conservative index for this subgroup is -.00058. If you expect a close panel vote with a margin closer than 70/30, then based on our logistic regression of past panels with greater than 70/30 splits, we estimate a 91% chance that this panel will vote for approval.
IMPORTANT: This behavioral analysis is secondary to a scientific analysis. A thorough analysis of safety and efficacy should form the cornerstone of any due diligence, as safety and efficacy are the primary concern of the FDA. Please consider this behavioral data as a supplemental factor if the outcome remains unclear after evaluating the safety and efficacy.
Denosumab’s FDA briefing documents largely match the opinion of a Lancet editorial. Based on no overall survival benefit and less than stellar alternative endpoints, we went on the record in Adam Feuerstein’s contest saying denosumab would receive a CRL.
If you have the opposite opinion and think the decision could favor approval, we hope this voting record data will be helpful to you.
For an explanation of the table headers, please see the “individual results” section of the methods page.
|Name||Num Votes||Proportion Yes||Proportion No||Proportion Abstain||Num Informative Votes||Num Inverse Yes||Inverse Yes||Num Inverse No||Inverse No||Liberal-Conservative Index||Maverick-Conformist Index|