Temporal trends in oncology product approvals in the United States, 1986–2005

Abstract

6131 Background: No systematic examination of temporal trends in oncology approvals in the United States (US) has been conducted. Methods: Internal databases at the US Food and Drug Administration (FDA) were queried to determine the number of first-time approvals for New Molecular Entities (NMEs) (both traditional drugs and therapeutic biologics) for oncology indications between the years 1986 and 2005, inclusive; 1986 was the first year for which database records were available for both drugs and biologics. Correlation analysis was used to analyze the data for time-dependent changes in approvals and approval rates. Results: During the period examined, 70 NMEs received first-time approval for an oncology indication ( Table ); 52 (74%) were drugs and 18 were biologics. The median annual number of approvals was 3 (range, 1 to 7); the maximum number of approvals during the period examined occurred in 2004. Statistical analysis showed a weak positive correlation between the number of oncology approvals and time, and between the proportion of applications approved as a percentage of all oncology product applications and time. Conclusions: Available data suggest that the number and rate of oncology product approvals has remained stable in the US over the last two decades. [Table: see text] No significant financial relationships to disclose.