Abstract
In this commentary, we review the timeline of clinical trials and regulatory actions of approved immune checkpoint inhibitors for small cell lung cancer, discuss challenges faced by regulatory agencies, and highlight paradoxical lessons that emerge. Accelerated approvals may fail to expedite drugs to market in this setting and further research on overall survival benefit is needed to prove drug efficacy.
Keywords:
FDA; immunotherapy; small cell lung cancer; surrogate endpoints.
Copyright © 2020 Elsevier Inc. All rights reserved.
Publication types
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Research Support, Non-U.S. Gov't
MeSH terms
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Clinical Trials as Topic / standards
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Clinical Trials as Topic / statistics & numerical data
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Drug Approval / statistics & numerical data*
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Humans
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Immune Checkpoint Inhibitors / therapeutic use*
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Lung Neoplasms / drug therapy*
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Lung Neoplasms / mortality
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Progression-Free Survival
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Research Design / standards
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Small Cell Lung Carcinoma / drug therapy*
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Small Cell Lung Carcinoma / mortality
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Time Factors
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United States
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United States Food and Drug Administration / legislation & jurisprudence
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United States Food and Drug Administration / standards
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United States Food and Drug Administration / statistics & numerical data
Substances
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Immune Checkpoint Inhibitors