PCN130 - Approvals And Market Discontinuations Of Oncology Drugs In The United States (1980-2012)

Abstract

We sought to describe the new molecular entities (NMEs) and new therapeutic biologic applications (BLAs) approved by the US Food and Drug Administration (FDA) in the period 1980-2012, and to assess differences in drug approvals and discontinuations between oncology products and products from other therapeutic classes. Drug approval data were collected from FDA databases publicly available on its website, and the FDA Approved Drug Products with Therapeutic Equivalence Evaluations (1980-2012). The unit of analysis was the pharmaceutical active ingredient or combination of ingredients approved by the FDA. Data were updated to December 31, 2012. Descriptive analysis and the chi-square test were used in the analysis. The FDA listed 2,479 approved active ingredients or combinations of active ingredients in the period 1980-2012; including 99 BLAs and 2,380 NMEs. Oncology products represented 5.3% (n=126) of NMEs and 43.4% (n=43) of BLAs. The FDA listed 34 oncology products approved before 1980, 12 in the 1980s, 49 in the 1990s, 51 in the 2000s, and 23 in 2010-2012. The oncology products (0.6%) and other products (23.8%) were approved as a fixed-dose combination (p<0.001). In January 1, 1980 the FDA listed 949 products of which 33 (3.5%) were oncology products. In the period 1980-2012, the FDA approved 1,530 products, including 136 oncology products (8.9%). In December 31, 2013, 92.9% of all the approved oncology products and 68.7% of other products were listed as marketed by the FDA (p<0.001). Oncology drugs experienced a rapid increase in approvals in the past 2 decades while the approvals in other therapeutic classes declined significantly. Biologics represented a larger proportion of the approvals of oncology products than products from other therapeutic classes. Pharmaceutical companies continue to invest in R&D in oncology and other niche markets without adequate therapeutic alternatives.