open access

Vol 16, No 6 (2020)
Review paper
Published online: 2021-01-12
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New dosing schedule of pembrolizumab — theoretical basis and scientific evidence

Dorota Szcześ, Piotr Rutkowski
DOI: 10.5603/OCP.2020.0033
·
Oncol Clin Pract 2020;16(6):358-363.

open access

Vol 16, No 6 (2020)
REVIEW ARTICLES
Published online: 2021-01-12

Abstract

Pembrolizumab among other immunotherapy agents is a breakthrough drug in oncology. Its wide therapeutic index allowed evolution from a dosing schedule based on body mass 2 mg/kg to a fixed-dose 200 mg every 3 weeks. In 2019 the European Medicines Agency approved dosing 400 mg every 6 weeks, despite lack of evidence from clinical trials on safety and efficacy, based only on pharmacokinetic data derived from previous clinical studies. This year, facing the SARS-CoV-2 pandemic, international oncology societies recommended a new dosing schedule in order to minimise patient exposition to health care units. In April 2020 the US Food and Drug Administration also approved a new dosing schedule, based on an interim analysis of clinical trial Keynote-555.

Abstract

Pembrolizumab among other immunotherapy agents is a breakthrough drug in oncology. Its wide therapeutic index allowed evolution from a dosing schedule based on body mass 2 mg/kg to a fixed-dose 200 mg every 3 weeks. In 2019 the European Medicines Agency approved dosing 400 mg every 6 weeks, despite lack of evidence from clinical trials on safety and efficacy, based only on pharmacokinetic data derived from previous clinical studies. This year, facing the SARS-CoV-2 pandemic, international oncology societies recommended a new dosing schedule in order to minimise patient exposition to health care units. In April 2020 the US Food and Drug Administration also approved a new dosing schedule, based on an interim analysis of clinical trial Keynote-555.

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Keywords

pembrolizumab; immunotherapy; dosing schedule

About this article
Title

New dosing schedule of pembrolizumab — theoretical basis and scientific evidence

Journal

Oncology in Clinical Practice

Issue

Vol 16, No 6 (2020)

Article type

Review paper

Pages

358-363

Published online

2021-01-12

DOI

10.5603/OCP.2020.0033

Bibliographic record

Oncol Clin Pract 2020;16(6):358-363.

Keywords

pembrolizumab
immunotherapy
dosing schedule

Authors

Dorota Szcześ
Piotr Rutkowski

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