Premium
Clinical Development and Initial Approval of Novel Immune Checkpoint Inhibitors in Oncology: Insights From a Global Regulatory Perspective
Author(s) -
Serrano Philippe,
Hartmann Markus,
Schmitt Elmar,
Franco Pedro,
Amexis Georgios,
Gross Jan,
MayerNicolai Christine
Publication year - 2019
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.1123
Subject(s) - drug development , regulatory science , perspective (graphical) , clinical oncology , medicine , drug approval , narrative review , biomarker , oncology , clinical research , clinical trial , clinical pharmacology , immune checkpoint , intensive care medicine , drug , immunotherapy , cancer , pharmacology , biology , pathology , computer science , biochemistry , artificial intelligence
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.