Discontinued drugs in 2012: oncology drugs
1Cancer Research UK, Drug Development Office , Angel Building, 407 St John Street, London EC1V 4AD , UK +44 203 469 6900 ; robert.williams@cancer.org.uk.
Abstract:
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.
Insights
In 2012, 29 oncology drugs were discontinued, with many Phase I failures due to strategic reasons and limited biomarker use. Phase III failures were mainly due to lack of efficacy, with no stratification biomarkers employed.
Area of Science:
- Oncology
- Drug Development
- Clinical Trials
Background:
- Analysis of oncology drug pipeline terminations in 2012.
- Identifies trends in drug discontinuation across clinical trial phases.
- Contextualizes findings within the evolving landscape of anticancer drug development.
Purpose of the Study:
- To report on drugs discontinued from the global oncology pipeline in 2012.
- To analyze the reasons for discontinuation, particularly in early and late phases.
- To discuss the implications for anticancer drug development strategies.
Main Methods:
- Review of 29 drugs discontinued globally in 2012.
- Categorization of discontinuations by clinical trial phase (Phase I, Phase III).
- Assessment of biomarker incorporation (stratification, pharmacodynamic) in study designs.
Main Results:
- 13 Phase I terminations, primarily for strategic/unspecified reasons; limited biomarker use.
- 7 drugs failed in Phase III, with 6 due to lack of efficacy.
- No Phase III studies utilized stratification biomarkers.
Conclusions:
- Early and late-stage oncology drug development faces significant attrition.
- Limited use of biomarkers in trial design may contribute to failures.
- Increased collaboration is fostering more drug approvals despite development challenges.
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