Abstract
Background: An increasing number of medicines authorised in Europe recommend or require biomarker-based patient selection. For some of these the use of a companion diagnostic (CDx), a subset of in vitro diagnostics (IVDs), to identify patient populations eligible for a specific medicinal product may be required. The information and recommendations of use of a medicinal product for which a CDx is required is particularly important to healthcare professionals for correct patient identification.Methods: We reviewed the existing information in SmPCs and European Public Assessment Reports (EPARs) of EU medicinal products approved via the centralised procedure at EMA where reference was made to biomarker testing, including by CDx, for patient selection.Results: The results show that varying levels of detail are provided for the biomarker and the diagnostic test, including variability in where the information was presented. The overall results demonstrate transparent but sometimes heterogeneous reporting of CDx in the SmPC and EPAR.Conclusions: With the introduction of the new Regulation (EU) 2017/746 on in vitro diagnostic medical devices, medicines regulatory authorities' will be required to be consulted during the review of CDx conformity assessment and so, there is opportunity for more consistent and transparent information on CDx to be provided in the SmPC and EPAR.
Highlights
Healthcare has been experiencing an important change in its treatment paradigm towards personalised medicine [1]
The identified 28 medicinal products were grouped into five main categories based on the level of detail provided for the biomarker and/or the diagnostic test, i.e., was a CE-marked test available and referenced either in Summaries of Product Characteristic (SmPC) and/or European public assessment report (EPAR), was a specific diagnostic test or methodology described and whether the information was described in the corresponding SmPC and/or EPAR (Table 3)
The first category included medicinal products where the CE marked commercial test was used during the development and specific information on the diagnostic test was referenced in section 5.1 of the SmPC, while the same level of information was not found in the EPAR
Summary
Healthcare has been experiencing an important change in its treatment paradigm towards personalised medicine [1]. The increasing development of “omics” methods have enabled the identification of patients and the prediction of their treatment response through measuring new biological markers (biomarkers). These are critical for the success of personalised medicine, often referred to as precision medicine or precision therapy. When IVDs are used to identify patients suitable for a specific treatment with a medicinal product they are generally referred to as companion diagnostics (CDx) [3]. An increasing number of medicines authorised in Europe recommend or require biomarker-based patient selection For some of these the use of a companion diagnostic (CDx), a subset of in vitro diagnostics (IVDs), to identify patient populations eligible for a specific medicinal product may be required. The information and recommendations of use of a medicinal product for which a CDx is required is important to healthcare professionals for correct patient identification
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