Uncertainties about the benefit-risk balance of oncology medicines assessed by the European Medicines Agency
At the time of initial marketing authorisation of oncology medicines, uncertainties about their benefit-risk balance most often concerned safety aspects, followed by efficacy. The number of uncertainties was highest for cell and gene therapies, conditionally authorised medicines, and medicines authorised in recent years.
Authors
- Francesco Pignatti (ORCID: https://orcid.org/0000-0001-9296-2474)
- Toine C. G. Egberts (ORCID: https://orcid.org/0000-0003-1758-7779)
- Anne C. Taams (ORCID: https://orcid.org/0000-0002-3002-3911)
- Lourens T. Bloem (ORCID: https://orcid.org/0000-0002-0014-8625)
- Nikolaos Zafiropoulos
- Carla Herberts
Institutions
- European Medicines Agency (NL)
- Utrecht University (NL)
- University Medical Center Utrecht (NL)
- Pharmo Institute (NL)
- Medicines Evaluation Board (NL)
Publication Details
- Journal
- ESMO Open
- Published
- 2024-12-01
- DOI
- https://doi.org/10.1016/j.esmoop.2024.103991
- Citations
- 3
- Primary Topic
- Economic and Financial Impacts of Cancer
- Type
- article
- Field-Weighted Citation Impact
- 3.39
Funders
- College ter Beoordeling van Geneesmiddelen