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      Cancer Immunotherapy Update: FDA-Approved Checkpoint Inhibitors and Companion Diagnostics

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          Abstract

          Immune checkpoint inhibitors (ICIs) are considered a new standard-of-care across many cancer indications. This review provides an update on ICIs approved by the Food and Drug Administration (FDA), with focus on monoclonal antibodies that target the programmed cell death 1 (PD-1) or its ligand, PD-1 ligand 1 (PD-L1), including information on their clinical indications and associated companion diagnostics. The information is further discussed with strategies for identifying predictive biomarkers to guide the clinical use of PD-1/PD-L1-targeted therapies.

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          Most cited references79

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          Pembrolizumab versus Chemotherapy for PD-L1–Positive Non–Small-Cell Lung Cancer

          Pembrolizumab is a humanized monoclonal antibody against programmed death 1 (PD-1) that has antitumor activity in advanced non-small-cell lung cancer (NSCLC), with increased activity in tumors that express programmed death ligand 1 (PD-L1).
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            Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma

            The combination of atezolizumab and bevacizumab showed encouraging antitumor activity and safety in a phase 1b trial involving patients with unresectable hepatocellular carcinoma.
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              Nivolumab versus Docetaxel in Advanced Nonsquamous Non–Small-Cell Lung Cancer

              Nivolumab, a fully human IgG4 programmed death 1 (PD-1) immune-checkpoint-inhibitor antibody, disrupts PD-1-mediated signaling and may restore antitumor immunity.
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                Author and article information

                Contributors
                Julianne.Twomey@fda.hhs.gov
                Baolin.zhang@fda.hhs.gov
                Journal
                AAPS J
                AAPS J
                The AAPS Journal
                Springer International Publishing (Cham )
                1550-7416
                7 March 2021
                7 March 2021
                March 2021
                : 23
                : 2
                : 39
                Affiliations
                GRID grid.417587.8, ISNI 0000 0001 2243 3366, Office of Biotechnology Products, Center for Drug Evaluation and Research, , Food and Drug Administration, ; Silver Spring, Maryland 20993 USA
                Author notes

                Guest Editors: Baolin Zhang and Mario L. Rocci Jr.

                Article
                574
                10.1208/s12248-021-00574-0
                7937597
                33677681
                c353b8c1-49f7-47d7-8c6f-8ce62dda772b
                © This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply 2021

                Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

                History
                : 13 January 2021
                : 15 February 2021
                Categories
                Review Article
                Custom metadata
                © American Association of Pharmaceutical Scientists 2021

                Pharmacology & Pharmaceutical medicine
                cancer immunotherapy,immune checkpoint inhibitor,biomarker,companion diagnostic

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