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

ABSTRACT:

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 identifie

SUBMITTER: Ruuskanen AM 

PROVIDER: S-EPMC11499751 | biostudies-literature | 2024 Oct

REPOSITORIES: biostudies-literature