Retifanlimab: First Approval

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 

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

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.

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.

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

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.

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.

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/.

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.

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.

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.

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.

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.

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.

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.

Data on file, Incyte Corporation, 2023.

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 

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.

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.

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.

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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