Abstract
Immune checkpoint inhibitors (ICI) have demonstrated meaningful patterns of clinical efficacy across various cancers. During their development, novel regulatory strategies and clinical design approaches were explored. This metrics-based narrative review examines submission strategies and clinical evidence expectations of the US, European, and Japanese drug agencies, as well as their impact on approval and overall development times. Also discussed is the role of emerging clinical science and biomarker evaluation to get the first six ICI initially approved.
© 2018 American Society for Clinical Pharmacology and Therapeutics.
Publication types
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Research Support, Non-U.S. Gov't
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Review
MeSH terms
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Antineoplastic Agents, Immunological / immunology
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Antineoplastic Agents, Immunological / therapeutic use*
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Clinical Trials as Topic / methods
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Drug Approval / legislation & jurisprudence*
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Drug Development / legislation & jurisprudence*
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Drug Development / trends
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Humans
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Immunologic Factors / immunology
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Immunologic Factors / therapeutic use
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Immunotherapy / legislation & jurisprudence*
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Immunotherapy / trends
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Medical Oncology / legislation & jurisprudence*
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Medical Oncology / trends
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Neoplasms / drug therapy*
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Neoplasms / immunology
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Neoplasms / therapy
Substances
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Antineoplastic Agents, Immunological
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Immunologic Factors