New cancer medicines in Europe 2010-2020: comparison of medicines with or without extensions of indications.

INTRODUCTION

During 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 METHODS

We 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.

RESULTS

We 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.

CONCLUSIONS

Based 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.