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. 2023 Aug;28(8):103620.
doi: 10.1016/j.drudis.2023.103620. Epub 2023 May 16.

Targeted combination therapies in oncology: Challenging regulatory frameworks designed for monotherapies in Europe

Julie M Vancoppenolle  1 , Simone N Koole  2 , James F O'Mahony  3 , Nora Franzen  1 , Jacobus A Burgers  2 , Valesca P Retèl  4 , Willem H van Harten  5
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Free article

Targeted combination therapies in oncology: Challenging regulatory frameworks designed for monotherapies in Europe

Julie M Vancoppenolle et al. Drug Discov Today. 2023 Aug.
Free article

Abstract

The pharmaceutical value chain, including clinical trials, pricing, access, and reimbursement, is designed for classical monotherapies. Although there has been a paradigm shift that increases the relevance of targeted combination therapies (TCTs), regulation and common practice have been slow to adapt. We explored access to 23 TCTs for advanced melanoma and lung cancer as reported by 19 specialists from 17 leading cancer institutions in nine European countries. We find heterogeneous patient access to TCTs between countries, differences in country-specific regulations, and differences in the clinical practice of melanoma and lung cancer. Regulation that is better tailored to the context of combinational therapies can increase equity in access across Europe and promote an evidence-based and authorized use of combinations.

Keywords: Europe; access; lung cancer; melanoma; pricing and reimbursement; research and development; targeted combination therapy.

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Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: ‘The authors have nothing to disclose for the work under consideration for publication. Prof. van Harten reported non restricted grants from Novartis, Intuitive Surgical and Agendia all ending over three years ago, Prof. Retèl reported non restricted grants from Intuitive and Agendia outside the submitted work. Dr. Burgers reported funding of an investigator initiated study by MSD and consultancy for Roche (payments to his institution). The other authors have nothing to declare.’.

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