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Review
. 2023 Jun;83(8):731-737.
doi: 10.1007/s40265-023-01884-7.

Retifanlimab: First Approval

Connie Kang  1
Affiliations
Review

Retifanlimab: First Approval

Connie Kang. Drugs. 2023 Jun.

Abstract

Retifanlimab (retifanlimab-dlwr; ZYNYZTM) is a programmed cell death 1 receptor-blocking antibody that is being developed by Incyte Corporation for the treatment of solid tumours, both as monotherapy and in combination with other agents. Retifanlimab recently received accelerated approval for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma. This article summarizes the milestones in the development of retifanlimab leading to this first approval for Merkel cell carcinoma.

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References

    1. Gauci M-L, Aristei C, Becker JC, et al. Diagnosis and treatment of Merkel cell carcinoma: European consensus-based interdisciplinary guideline—update 2022. Eur J Cancer. 2022;171:P203–31. - DOI
    1. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: Merkel cell carcinoma version 1. 2023. https://www.nccn.org . Accessed 26 Apr 2023.
    1. Incyte Corporation. ZYNYZ™ (retifanlimab-dlwr) injection, for intravenous use: US prescribing information. 2023. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSea... . Accessed 26 Apr 2023.
    1. U.S. Food & Drug Administration. FDA grants accelerated approval to retifanlimab-dlwr for metastatic or recurrent locally advanced Merkel cell carcinoma. [media release] 22 Mar 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grant... .
    1. Incyte Corporation. Pharmaceutical portfolio. 2023. https://www.incyte.com/what-we-do/pharmaceutical-portfolio . Accessed 26 Apr 2023.

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