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

Drug Discovery Today（2023）

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摘要

•Inequality in access to targeted combination therapies (TCTs) across EU-countries.•The pharmaceutical value chain tailored to monotherapies presents barriers to TCTs.•We survey access & identify regulatory challenges to TCTs in 9 EU-countries.•The current pharmaceutical environment fails to incentivize financially sustainable development of TCTs.•Recommendations to close regulatory gaps in R&D and P&R process to improve access.

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