Cargando…

Significance and implications of FDA approval of pembrolizumab for biomarker-defined disease

The U.S. Food and Drug Administration (FDA) recently approved pembrolizumab, an anti- programmed cell death protein 1 cancer immunotherapeutic, for use in advanced solid tumors in patients with the microsatellite-high/DNA mismatch repair-deficient biomarker. This is the first example of a tissue-agn...

Descripción completa

Detalles Bibliográficos
Autores principales: Boyiadzis, Michael M., Kirkwood, John M., Marshall, John L., Pritchard, Colin C., Azad, Nilofer S., Gulley, James L.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5950135/
https://www.ncbi.nlm.nih.gov/pubmed/29754585
http://dx.doi.org/10.1186/s40425-018-0342-x
_version_ 1783322828614926336
author Boyiadzis, Michael M.
Kirkwood, John M.
Marshall, John L.
Pritchard, Colin C.
Azad, Nilofer S.
Gulley, James L.
author_facet Boyiadzis, Michael M.
Kirkwood, John M.
Marshall, John L.
Pritchard, Colin C.
Azad, Nilofer S.
Gulley, James L.
author_sort Boyiadzis, Michael M.
collection PubMed
description The U.S. Food and Drug Administration (FDA) recently approved pembrolizumab, an anti- programmed cell death protein 1 cancer immunotherapeutic, for use in advanced solid tumors in patients with the microsatellite-high/DNA mismatch repair-deficient biomarker. This is the first example of a tissue-agnostic FDA approval of a treatment based on a patient’s tumor biomarker status, rather than on tumor histology. Here we discuss key issues and implications arising from the biomarker-based disease classification implied by this historic approval.
format Online
Article
Text
id pubmed-5950135
institution National Center for Biotechnology Information
language English
publishDate 2018
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-59501352018-05-21 Significance and implications of FDA approval of pembrolizumab for biomarker-defined disease Boyiadzis, Michael M. Kirkwood, John M. Marshall, John L. Pritchard, Colin C. Azad, Nilofer S. Gulley, James L. J Immunother Cancer Review Article The U.S. Food and Drug Administration (FDA) recently approved pembrolizumab, an anti- programmed cell death protein 1 cancer immunotherapeutic, for use in advanced solid tumors in patients with the microsatellite-high/DNA mismatch repair-deficient biomarker. This is the first example of a tissue-agnostic FDA approval of a treatment based on a patient’s tumor biomarker status, rather than on tumor histology. Here we discuss key issues and implications arising from the biomarker-based disease classification implied by this historic approval. BioMed Central 2018-05-14 /pmc/articles/PMC5950135/ /pubmed/29754585 http://dx.doi.org/10.1186/s40425-018-0342-x Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Review Article
Boyiadzis, Michael M.
Kirkwood, John M.
Marshall, John L.
Pritchard, Colin C.
Azad, Nilofer S.
Gulley, James L.
Significance and implications of FDA approval of pembrolizumab for biomarker-defined disease
title Significance and implications of FDA approval of pembrolizumab for biomarker-defined disease
title_full Significance and implications of FDA approval of pembrolizumab for biomarker-defined disease
title_fullStr Significance and implications of FDA approval of pembrolizumab for biomarker-defined disease
title_full_unstemmed Significance and implications of FDA approval of pembrolizumab for biomarker-defined disease
title_short Significance and implications of FDA approval of pembrolizumab for biomarker-defined disease
title_sort significance and implications of fda approval of pembrolizumab for biomarker-defined disease
topic Review Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5950135/
https://www.ncbi.nlm.nih.gov/pubmed/29754585
http://dx.doi.org/10.1186/s40425-018-0342-x
work_keys_str_mv AT boyiadzismichaelm significanceandimplicationsoffdaapprovalofpembrolizumabforbiomarkerdefineddisease
AT kirkwoodjohnm significanceandimplicationsoffdaapprovalofpembrolizumabforbiomarkerdefineddisease
AT marshalljohnl significanceandimplicationsoffdaapprovalofpembrolizumabforbiomarkerdefineddisease
AT pritchardcolinc significanceandimplicationsoffdaapprovalofpembrolizumabforbiomarkerdefineddisease
AT azadnilofers significanceandimplicationsoffdaapprovalofpembrolizumabforbiomarkerdefineddisease
AT gulleyjamesl significanceandimplicationsoffdaapprovalofpembrolizumabforbiomarkerdefineddisease