Assessing outcomes emerging after conversion to regular approval for cancer drug indications granted accelerated approval, 1992-2021
Once oncology drugs are converted from accelerated to full approval, new evidence of OS or QoL gains remains rare, underscoring the need to ensure such evidence is available at conversion. Patients should be informed of evidence variability, and the ESMO-MCBS can provide valuable guidance.
Authors
- Ian T. T. Liu
- Ariadna Tibau (ORCID: https://orcid.org/0000-0003-0229-6987)
- Aaron Seth Kesselheim (ORCID: https://orcid.org/0000-0002-8867-2666)
- Alejandra Romano (ORCID: https://orcid.org/0000-0002-0669-4440)
- Edward R. Scheffer Cliff (ORCID: https://orcid.org/0000-0001-5977-907X)
- Jiali Han (ORCID: https://orcid.org/0009-0005-6068-0188)
Institutions
- Universitat Autònoma de Barcelona (ES)
- Brigham and Women's Hospital (US)
- The Royal Melbourne Hospital (AU)
- Harvard University (US)
- Peter MacCallum Cancer Centre (AU)
- Hospital de Sant Pau (ES)
Publication Details
- Journal
- JNCI Journal of the National Cancer Institute
- Published
- 2025-07-14
- DOI
- https://doi.org/10.1093/jnci/djaf195
- Citations
- 1
- Primary Topic
- Health Systems, Economic Evaluations, Quality of Life
- Type
- article
- Field-Weighted Citation Impact
- 3.13