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

Julie M Vancoppenolle ,
Simone N Koole ,
James F O'Mahony ,
Nora Franzen ,
Jacobus A Burgers ,
Valesca P Retèl ,
Willem H van Harten

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.

More about this publication

Drug discovery today

Volume 28
Issue nr. 8
Pages 103620
Publication date 01-08-2023

Full text links

Publisher website (DOI) 10.1016/j.drudis.2023.103620
Europe PubMed Central 37201780
Pubmed 37201780

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