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Review
. 2024;18(6):265-277.
doi: 10.2217/bmm-2023-0048. Epub 2024 Mar 15.

Potential biomarkers in breast cancer drug development: application of the biomarker qualification evidentiary framework

Eric Wang  1 , Mackenzie Henderson  1 , Priyanka Yalamanchili  1   2 , Jenilee Cueto  1 , Zahidul Islam  1 , Charles Dharmani  1 , Maribel Salas  1   3
Affiliations
Review

Potential biomarkers in breast cancer drug development: application of the biomarker qualification evidentiary framework

Eric Wang et al. Biomark Med. 2024.

Abstract

Breast cancer treatments have evolved rapidly, and clinically meaningful biomarkers have been used to guide therapy. These biomarkers hold utility within the drug development process to increase the efficiency and effectiveness. To this purpose, the US FDA developed an evidentiary framework. Literature searches conducted of literature published between 2016 and 2022 identified biomarkers in breast cancer. These biomarkers were reviewed for drug development utility through the biomarker qualification evidentiary framework. In the breast cancer setting, several promising biomarkers (ctDNA, Ki-67 and PIK3CA) were identified. There is a need for increased transparency regarding the requirements for qualification of specific biomarkers and increased awareness of the processes involved in biomarker qualification.

Keywords: biomarkers; breast cancer; diagnostic; drug development; framework; monitoring; predictive; prognostic; qualification; review.

Plain language summary

[Box: see text].

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Conflict of interest statement

E Wang, M Henderson, P Yalamanchili, Z Islam, C Dharmani and M Salas are full-time employees of Daiichi Sankyo. J Cueto was a part-time employee of Daiichi Sankyo at the time of writing. All own restricted stock units of Daiichi Sankyo, except E Wang, M Henderson, P Yalamanchili and J Cueto. The authors have no other competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript apart from those disclosed.

Figures

Figure 1.
Figure 1.
Biomarker qualification evidentiary framework. This figure describes the different sections required for a biomarker submission package to the FDA through the biomarker qualification program. Adapted from Framework for Defining Evidentiary Criteria for Biomarker Qualification [11].
Figure 2.
Figure 2.
Possible drug development uses using Biomarkers, EndpointS and other tools biomarker categories. This figure describes examples of how a biomarker can be utilized in the drug development process. Adapted from CDER: Context of Use [13].
See this image and copyright information in PMC

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