Factors in Time to Full Approval or Withdrawal for Anticancer Medicines Granted Accelerated Approval by the FDA
In this cohort study, drugs with low clinical benefit or safety concerns at accelerated approval were linked to delayed confirmatory studies, while high clinical benefit in confirmatory trials correlated with faster conversion. These associations can help guide patient decision-making around accelerated approval drugs.
Authors
- Thomas J. Hwang (ORCID: https://orcid.org/0000-0003-0717-1497)
- María Borrell (ORCID: https://orcid.org/0009-0001-6457-9707)
- Ariadna Tibau
- Ignasi Gich (ORCID: https://orcid.org/0000-0003-3975-6588)
- Consolación Moltó
- Aaron Seth Kesselheim (ORCID: https://orcid.org/0000-0002-8867-2666)
- Alejandra Romano (ORCID: https://orcid.org/0000-0002-0669-4440)
Institutions
- Universitat Autònoma de Barcelona (ES)
- Brigham and Women's Hospital (US)
- Harvard University (US)
- Queen's University (CA)
- Regional Municipality of Durham (CA)
- Hospital de Sant Pau (ES)
- Dana-Farber Cancer Institute (US)
- Vall d'Hebron Hospital Universitari (ES)
- Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública (ES)
- Vall d'Hebron Institute of Oncology (ES)
Publication Details
- Journal
- JAMA Network Open
- Published
- 2025-03-26
- DOI
- https://doi.org/10.1001/jamanetworkopen.2025.2026
- Citations
- 13
- Primary Topic
- Economic and Financial Impacts of Cancer
- Type
- article
- Field-Weighted Citation Impact
- 40.70
Funders
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- Gilead Sciences
- Kaiser Permanente
- Arnold Ventures
- Daiichi Sankyo Europe