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Review
. 2021 Jul;81(10):1213-1219.
doi: 10.1007/s40265-021-01539-5.

Dostarlimab: First Approval

Anthony Markham  1
Affiliations
Review

Dostarlimab: First Approval

Anthony Markham. Drugs. 2021 Jul.

Abstract

Dostarlimab (Jemperli™; GlaxoSmithKline) is a humanized monoclonal antibody programmed death-1 (PD-1) receptor antagonist being developed for the treatment of various cancers. Based on preliminary results from the GARNET trial dostarlimab has recently been approved in the EU and USA for the treatment of adult patients with mismatch repair deficient recurrent or advanced endometrial cancer. This article summarizes the milestones in the development of dostarlimab leading to these first approvals.

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References

    1. Food & Drug Administration. FDA grants accelerated approval to dostarlimab-gxly for dMMR endometrial cancer [media release]. 22 Apr 2021. https://www.fda.gov/drugs .
    1. GlaxoSmithKline. Jemperli (Dostarlimab): US prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761174s000lbl.pdf . Accessed 27 May 2021.
    1. GlaxoSmithKline. European Commission approves GSK’s JEMPERLI (dostarlimab), the first anti-PD-1 therapy approved for recurrent or advanced endometrial cancer [media release]. 23 Apr 2021. https://www.gsk.com .
    1. GlaxoSmithKline. Jemperli (Dostarlimab) summary of product characteristics (SmPC). 2021. https://www.ema.europa.eu/en/medicines/human/summaries-opinion/jemperli . Accessed 7 May
    1. GlaxoSmithKline, Tesaro. GSK completes acquisition of TESARO, an oncology focused biopharmaceutical company [media release]. 22 Jan 2019. https://www.gsk.com .

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