Discrepancies in the therapeutic indications granted by the European Medicines Agency and the US Food and Drug Administration for new cancer drugs: An analysis of potential explanations
Discrepancies between regulatory agencies in the indications granted to new cancer drugs suggest a problematic extrapolation and thus uncertainty regarding the clinical benefit for the patients. The present study seeks to identify potential explanations for the discrepancies to reduce the misalignment in the future.
Authors
- Allan Cramer (ORCID: https://orcid.org/0000-0002-1896-0478)
- Tonny Studsgaard Petersen (ORCID: https://orcid.org/0000-0002-9974-2738)
- Kristian Karstoft (ORCID: https://orcid.org/0000-0002-6596-4199)
- Freja Karuna Hemmingsen Sørup (ORCID: https://orcid.org/0000-0002-6089-5809)
- Hanne Rolighed Christensen
Institutions
- Frederiksberg Hospital (DK)
- Copenhagen University Hospital (DK)
Publication Details
- Journal
- Journal of Cancer Policy
- Published
- 2025-11-05
- DOI
- https://doi.org/10.1016/j.jcpo.2025.100660
- Primary Topic
- Health Systems, Economic Evaluations, Quality of Life
- Type
- article
- Field-Weighted Citation Impact
- 0.00