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Retifanlimab: First Approval

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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.

    Article  Google Scholar 

  2. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: Merkel cell carcinoma version 1. 2023. https://www.nccn.org. Accessed 26 Apr 2023.

  3. Incyte Corporation. ZYNYZ™ (retifanlimab-dlwr) injection, for intravenous use: US prescribing information. 2023. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.proces. Accessed 26 Apr 2023.

  4. 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-grants-accelerated-approval-retifanlimab-dlwr-metastatic-or-recurrent-locally-advanced-merkel.

  5. Incyte Corporation. Pharmaceutical portfolio. 2023. https://www.incyte.com/what-we-do/pharmaceutical-portfolio. Accessed 26 Apr 2023.

  6. Incyte C. Incyte and MacroGenics announce global collaboration and licensing agreement for anti-PD-1 monoclonal antibody MGA012. [media release] 25 Oct 2017. http://ir.macrogenics.com/news-releases/news-release-details/incyte-and-macrogenics-announce-global-collaboration-and.

  7. MacroGenics. MacroGenics announces closing of MGA012 global collaboration and license agreement with Incyte. [media release] 5 Dec 2017. http://ir.macrogenics.com/news-releases/news-release-details/macrogenics-announces-closing-mga012-global-collaboration-and.

  8. BriaCell Therapeutics. BriaCell announces clinical trial collaboration agreement with Incyte. [media release] 2 Apr 2019. https://briacell.com/briacell-announces-clinical-trial-collaboration-agreement-with-incyte/.

  9. Zai Lab. Incyte and Zai Lab announce collaboration and license agreement for INCMGA0012 in greater China. [media release] 2 Jul 2019. https://ir.zailaboratory.com/news-releases/news-release-details/incyte-and-zai-lab-announce-collaboration-and-license-agreement.

  10. United States Securities and Exchange Commission. Macrogenics, Inc. Form 10-K filing. 2021. https://www.sec.gov/ix?doc=/Archives/edgar/data/1125345/000112534521000035/mgnx-20201231.htmv. Accessed 26 Apr 2023.

  11. Condamine T, Owens S, Feldman P, et al. Pharmacodynamic correlates in a phase I study of INCMGA00012, a PD-1 antagonistic monoclonal antibody [abstract no. CT085]. Cancer Res. 2019;79(Suppl. 13):CT085.

  12. Chen XJ, Wang P, Kaul S, et al. Assessment of flat dosing strategy for INCMGA00012 in patients with advanced tumors [abstract no. LB-268]. Cancer Res. 2019;79(Suppl. 13):LB-268.

  13. Berton D, Pautier P, Lorusso D, et al. Retifanlimab (INCMGA00012) in patients with recurrent MSI-H or dMMR endometrial cancer: results from the POD1UM-101 study [abstract no. 956]. J Immunother Cancer. 2021;9(Suppl. 2):A1006.

  14. Koyama T, Shimizu T, Matsubara N, et al. Phase 1 study of retifanlimab (anti-PD-1) and INCB001158 (arginase inhibitor), alone or in combination, in solid tumors [abstract no. MO10-6]. Ann Oncol. 2021;32(Suppl. 4):S302.

  15. Grignani G, Rutkowski P, Lebbe C, et al. A phase 2 study of retifanlimab in patients with advanced or metastatic merkel cell carcinoma (MCC) (POD1UM-201) [abstract no. 545]. J Immunother Cancer. 2021;9(Suppl. 2):A574-A5.

  16. Data on file, Incyte Corporation, 2023.

  17. Rao S, Anandappa G, Capdevila J, et al. A phase II study of retifanlimab (INCMGA00012) in patients with squamous carcinoma of the anal canal who have progressed following platinum-based chemotherapy (POD1UM-202). ESMO Open. 2022;7(4): 100529.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  18. Catenacci DV, Park H, Shim BY, et al. Margetuximab (M) with retifanlimab (R) in HER2+, PD-L1+ 1st-line unresectable/metastatic gastroesophageal adenocarcinoma (GEA): MAHOGANY cohort A [abstract no. 1379P]. Ann Oncol. 2021;32(Suppl. 5):S1043-S4.

  19. Maio M, Schenker M, Medioni J, et al. Phase 2 study of retifanlimab (INCMGA00012) in patients (pts) with selected solid tumors (POD1UM-203) [abstract no. 2571]. J Clin Oncol. 2021;39(Suppl. 15):2571.

  20. Butt O, Huang J, Luo J, et al. A phase II study of retifanlimab (PD-1 inhibitor) in combination with bevacizumab and hypofractionated radiotherapy for recurrent gliobastoma: NCT03532295 [abstract no. CTIM-10]. Neuro-oncology 2022;24(Suppl. 7):vii61.

  21. European Medicines Agency. Committee for medicinal products for human use (CHMP): agenda for the meeting on 27–30 March 2023. https://www.ema.europa.eu/en/events/committee-medicinal-products-human-use-chmp-27-30-march-2023. Accessed 26 Apr 2023.

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  1. Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand

    Connie Kang

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  1. Connie Kang
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Correspondence to Connie Kang.

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TThe preparation of this review was not supported by any external funding.

Authorship and Conflict of Interest

During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Connie Kang is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

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This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond.

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Kang, C. Retifanlimab: First Approval. Drugs 83, 731–737 (2023). https://doi.org/10.1007/s40265-023-01884-7

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