Discontinued drugs in 2012: oncology drugs.

This year's analysis of discontinued drugs in oncology reports on 29 drugs dropped from the global pipeline in 2012. Similar to the trends that were observed in 2011, there were a large number (13) of Phase I terminations reported, largely due to strategic or unspecified reasons. Only one of these Phase I discontinued drugs appeared to incorporate a patient stratification biomarker in the study design and only four studies incorporated pharmacodynamic biomarker analysis. Out of seven drugs failing in Phase III, six were reported to display a lack of efficacy. None of the Phase III studies investigating these agents incorporated stratification biomarkers in the trial design. The aim of this article is to highlight the cohort of drugs discontinued in 2012 and discuss their profile in the context of the evolving paradigm for anticancer drug development. It is noteworthy that while there is clearly still room for improvement in the efficiency of drug development, increased collaboration among academics, industry, regulators, government and not-for-profit organisations appears to be contributing to increased numbers of new drug approvals.