Letter to the Editor: Re: “Life Years Gained From the FDA Accelerated Approval Program in Oncology: A Portfolio Model”

Authors:
Ian T.T. Liu Program on Regulation, Therapeutics and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA

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 MD, JD, MPH, MS,
and
Aaron S. Kesselheim Program on Regulation, Therapeutics and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA

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 MD, JD, MPH
Volume/Issue:
Volume 22: Issue 7
Online Publication Date:
Sep 2024
DOI:
https://doi.org/10.6004/jnccn.2024.7043
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Print ISSN:
1540-1405
Online ISSN:
1540-1413
Publisher:
National Comprehensive Cancer Network
Cover Journal of the National Comprehensive Cancer Network
  • 1.

    Benedict Á, Szabó G, Marczell K, et al. Life years gained from the FDA Accelerated Approval Program in oncology: a portfolio model. J Natl Compr Canc Netw 2024;22:e247043.

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  • 2.

    Ladanie A, Speich B, Briel M, et al. Single pivotal trials with few corroborating characteristics were used for FDA approval of cancer therapies. J Clin Epidemiol 2019;114:49–59.

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  • 3.

    Chen EY, Joshi SK, Tran A, Prasad V. Estimation of study time reduction using surrogate end points rather than overall survival in oncology clinical trials. JAMA Intern Med 2019;179:642–647.

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  • 4.

    Wallach JD, Ramachandran R, Bruckner T, Ross JS. Comparison of duration of postapproval vs pivotal trials for therapeutic agents granted US Food and Drug Administration Accelerated Approval, 2009–2018. JAMA Netw Open 2021;4:e2133601.

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Copyright:
Copyright © 2024 by the National Comprehensive Cancer Network 2024
Article Category:
Letter
Print Publication Date:
01 Sep 2024
Online Publication Date:
Sep 2024

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