ArticleBMJ open2024
New cancer medicines in Europe 2010-2020: comparison of medicines with or without extensions of indications.
Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
3 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Trends in oncology marketing applications in the European Union: a five-year systematic review.Frontiers in pharmacology · 2025Pooled it
- Indication Expansion Dynamics and Trial Characteristics of Novel Multi-Indication Anti-Cancer Drugs in China (2000-2024): A Cross-Sectional Study.Drug design, development and therapy · 2026Article
- Primary endpoint acceptance and its association with benefit ratings and market access in German health technology assessments: a retrospective cohort study.The Lancet regional health. Europe · 2025Article
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionDuring the last decade, extensions of therapeutic indications have been one of the most common methods to extend the lifecycle of a medical product in the post-authorisation phase and to increase the use and sales of medicines. The aim of this study was to gain understanding of the lifecycle of cancer medicines and especially the role and level of evidence extensions in comparison to first indications. MATERIALS AND
methodsWe identified all new outpatient cancer medicines approved by the European Medicines Agency between 2010 and 2020 and the extensions to their indications. We compared general study design characteristics from the European public assessment reports using critical appraisal tools and clinical added value assessments.
resultsWe identified altogether 55 new outpatient cancer medicines, 31 of which had one or more extension(s) of indication and 24 had no extension of indication. In total, there were 57 extensions. The most common extension of indication was a change in the treatment line (35%). Compared with first indications, the overall quality of studies supporting extensions was better in terms of study designs. The proportion of medicines providing CAV was higher in extensions compared with first indication of medicines with and without extensions.
conclusionsBased on different assessments and perspectives, we found that extensions of indications are a very common and important part of extending the lifecycle of outpatient cancer medicines in Europe. Our findings also suggest that the clinical value of cancer medicines increases with extensions.
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