Evolution of preclinical characterization and insights into clinical pharmacology of checkpoint inhibitors approved for cancer immunotherapy

Abstract Cancer immunotherapy has significantly advanced the treatment paradigm in oncology, with approvals of immuno‐oncology agents for over 16 indications, many of them first line. Checkpoint inhibitors (CPIs) are recognized as an essential backbone for a successful anticancer therapy regimen. Th...

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Main Authors: Sreeneeranj Kasichayanula, Sandhya Mandlekar, Vittal Shivva, Maulik Patel, Sandhya Girish
Format: Article
Language:English
Published: Wiley 2022-08-01
Series:Clinical and Translational Science
Online Access:https://doi.org/10.1111/cts.13312
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author Sreeneeranj Kasichayanula
Sandhya Mandlekar
Vittal Shivva
Maulik Patel
Sandhya Girish
author_facet Sreeneeranj Kasichayanula
Sandhya Mandlekar
Vittal Shivva
Maulik Patel
Sandhya Girish
author_sort Sreeneeranj Kasichayanula
collection DOAJ
description Abstract Cancer immunotherapy has significantly advanced the treatment paradigm in oncology, with approvals of immuno‐oncology agents for over 16 indications, many of them first line. Checkpoint inhibitors (CPIs) are recognized as an essential backbone for a successful anticancer therapy regimen. This review focuses on the US Food and Drug Administration (FDA) regulatory approvals of major CPIs and the evolution of translational advances since their first approval close to a decade ago. In addition, critical preclinical and clinical pharmacology considerations, an overview of the pharmacokinetic and dose/regimen aspects, and a discussion of the future of CPI translational and clinical pharmacology as combination therapy becomes a mainstay of industrial immunotherapy development and in clinical practice are also discussed.
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spelling doaj.art-e322787f3a6a42109ffe1625db83470c2022-12-22T03:59:00ZengWileyClinical and Translational Science1752-80541752-80622022-08-011581818183710.1111/cts.13312Evolution of preclinical characterization and insights into clinical pharmacology of checkpoint inhibitors approved for cancer immunotherapySreeneeranj Kasichayanula0Sandhya Mandlekar1Vittal Shivva2Maulik Patel3Sandhya Girish4Gilead Sciences Foster City California USAGenentech South San Francisco California USAGenentech South San Francisco California USAAbbVie Inc. South San Francisco California USAGilead Sciences Foster City California USAAbstract Cancer immunotherapy has significantly advanced the treatment paradigm in oncology, with approvals of immuno‐oncology agents for over 16 indications, many of them first line. Checkpoint inhibitors (CPIs) are recognized as an essential backbone for a successful anticancer therapy regimen. This review focuses on the US Food and Drug Administration (FDA) regulatory approvals of major CPIs and the evolution of translational advances since their first approval close to a decade ago. In addition, critical preclinical and clinical pharmacology considerations, an overview of the pharmacokinetic and dose/regimen aspects, and a discussion of the future of CPI translational and clinical pharmacology as combination therapy becomes a mainstay of industrial immunotherapy development and in clinical practice are also discussed.https://doi.org/10.1111/cts.13312
spellingShingle Sreeneeranj Kasichayanula
Sandhya Mandlekar
Vittal Shivva
Maulik Patel
Sandhya Girish
Evolution of preclinical characterization and insights into clinical pharmacology of checkpoint inhibitors approved for cancer immunotherapy
Clinical and Translational Science
title Evolution of preclinical characterization and insights into clinical pharmacology of checkpoint inhibitors approved for cancer immunotherapy
title_full Evolution of preclinical characterization and insights into clinical pharmacology of checkpoint inhibitors approved for cancer immunotherapy
title_fullStr Evolution of preclinical characterization and insights into clinical pharmacology of checkpoint inhibitors approved for cancer immunotherapy
title_full_unstemmed Evolution of preclinical characterization and insights into clinical pharmacology of checkpoint inhibitors approved for cancer immunotherapy
title_short Evolution of preclinical characterization and insights into clinical pharmacology of checkpoint inhibitors approved for cancer immunotherapy
title_sort evolution of preclinical characterization and insights into clinical pharmacology of checkpoint inhibitors approved for cancer immunotherapy
url https://doi.org/10.1111/cts.13312
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