1. A Timeline of Immune Checkpoint Inhibitor Approvals in Small Cell Lung Cancer.
- Author
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Gill J, Cetnar JP, and Prasad V
- Subjects
- Clinical Trials as Topic standards, Clinical Trials as Topic statistics & numerical data, Humans, Lung Neoplasms mortality, Progression-Free Survival, Research Design standards, Small Cell Lung Carcinoma mortality, Time Factors, United States, United States Food and Drug Administration legislation & jurisprudence, United States Food and Drug Administration standards, United States Food and Drug Administration statistics & numerical data, Drug Approval statistics & numerical data, Immune Checkpoint Inhibitors therapeutic use, Lung Neoplasms drug therapy, Small Cell Lung Carcinoma drug therapy
- 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., (Copyright © 2020 Elsevier Inc. All rights reserved.)
- Published
- 2020
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