On-Label or Off-Label? Overcoming Regulatory and Financial Barriers to Bring Repurposed Medicines to Cancer Patients.
drug repositioning
drug repurposing
incentives
off-label use
oncology
policy
regulatory framework
Journal
Frontiers in pharmacology
ISSN: 1663-9812
Titre abrégé: Front Pharmacol
Pays: Switzerland
ID NLM: 101548923
Informations de publication
Date de publication:
2019
2019
Historique:
received:
15
11
2019
accepted:
19
12
2019
entrez:
21
2
2020
pubmed:
23
2
2020
medline:
23
2
2020
Statut:
epublish
Résumé
Repurposing of medicines has gained a lot of interest from the research community in recent years as it could offer safe, timely, and affordable new treatment options for cancer patients with high unmet needs. Increasingly, questions arise on how new uses will be translated into clinical practice, especially in case of marketed medicinal products that are out of basic patent or regulatory protection. The aim of this study was to portray the regulatory framework relevant for making repurposed medicines available to cancer patients in Europe and propose specific policy recommendations to address the current regulatory and financial barriers. We outlined two routes relevant to the clinical adoption of a repurposed medicine. First, a new indication can be approved, and thus brought on-label,
Identifiants
pubmed: 32076405
doi: 10.3389/fphar.2019.01664
pmc: PMC7006723
doi:
Types de publication
Journal Article
Langues
eng
Pagination
1664Informations de copyright
Copyright © 2020 Verbaanderd, Rooman, Meheus and Huys.
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