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*

*Corresponding author for this work

Research output: Contribution to journalShort surveyAcademicpeer-review

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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.

Original languageEnglish
Article number103620
Pages (from-to)1-5
Number of pages5
JournalDrug Discovery Today
Volume28
Issue number8
DOIs
Publication statusPublished - Aug 2023

Bibliographical note

Funding Information:
We are sincerely grateful to all participating oncologists, the European Fair Pricing Network (EFPN), and the Organisation of European Cancer Institutes. The project was funded by the EFPN. J.F.O'M. is supported by Ireland's Health Research Board (EIA-2017-054). The project has been funded by the EFPN. JFOM is supported by Ireland's Health Research Board (EIA-2017-054).

Publisher Copyright:
© 2023 The Authors

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