Trends in endpoint use in pivotal trials and efficacy for US Food and Drug Administration–approved solid tumor therapies, 1995-2021

We reviewed cancer therapies for solid tumors approved by the US Food and Drug Administration between 1995 and 2021. We found that there was a shift toward the use of surrogate endpoints and single-armed trials over time. Progression-free survival has increased by 3 months and overall survival has r...

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Bibliographic Details
Published in:Journal of managed care & specialty pharmacy 2022-11, Vol.28 (11), p.1219-1223
Main Authors: Alabaku, Orges, Laffey, Taylor N, Suh, Kangho, Li, Meng
Format: Article
Language:English
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Research Brief
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Summary:We reviewed cancer therapies for solid tumors approved by the US Food and Drug Administration between 1995 and 2021. We found that there was a shift toward the use of surrogate endpoints and single-armed trials over time. Progression-free survival has increased by 3 months and overall survival has remained stable over this time period.
ISSN:2376-0540
2376-1032
DOI:10.18553/jmcp.2022.28.11.1219