Retifanlimab
{{Short description|Medication}}
{{Use American English|date=March 2023}}
{{Use dmy dates|date=March 2023}}
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{{Infobox drug
| type = mab
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| mab_type = mab
| source = zu
| target = Programmed cell death protein 1 (PD-1)
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| tradename = Zynyz
| Drugs.com = {{drugs.com|parent|Zynyz}}
| MedlinePlus = a623017
| DailyMedID = Retifanlimab
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| routes_of_administration = Intravenous
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| ATC_prefix = L01
| ATC_suffix = FF10
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| legal_CA = Rx-only
| legal_CA_comment = {{cite web | title=Register of Innovative Drugs | website=Health Canada | date=3 November 2006 | url=https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/register-innovative-drugs.html | access-date=17 April 2025}}
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| legal_US = Rx-only
| legal_EU = Rx-only
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| CAS_number = 2079108-44-2
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| IUPHAR_ligand =
| DrugBank = DB15766
| ChemSpiderID =
| UNII = 2Y3T5IF01Z
| KEGG = D11827
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| PDB_ligand =
| synonyms = AEX-1188, INCMGA-00012, MGA-012, retifanlimab-dlwr
| IUPAC_name =
| C = 6456 | H = 9934 | N = 1702 | O = 2032 | S = 46
}}
Retifanlimab, sold under the brand name Zynyz, is an anti-cancer medication used for the treatment of Merkel cell carcinoma. Retifanlimab is a programmed death receptor-1 (PD-1)–blocking monoclonal antibody.
It was approved for medical use in the United States in March 2023,{{cite web | title=FDA grants accelerated approval to retifanlimab-dlwr for metastatic or recurrent locally advanced Merkel cell carcinoma | website=U.S. Food and Drug Administration (FDA) | date=22 March 2023 | url=https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-retifanlimab-dlwr-metastatic-or-recurrent-locally-advanced-merkel | access-date=22 March 2023 | archive-date=23 March 2023 | archive-url=https://web.archive.org/web/20230323054927/https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-retifanlimab-dlwr-metastatic-or-recurrent-locally-advanced-merkel | url-status=live }} {{PD-notice}}{{cite press release | title=Incyte Announces FDA Approval of Zynyz (retifanlimab-dlwr) for the Treatment of Metastatic or Recurrent Locally Advanced Merkel Cell Carcinoma (MCC) | publisher=Incyte | via=Business Wire | date=22 March 2023 | url=https://www.businesswire.com/news/home/20230322005618/en/Incyte-Announces-FDA-Approval-of-Zynyz%E2%84%A2-retifanlimab-dlwr-for-the-Treatment-of-Metastatic-or-Recurrent-Locally-Advanced-Merkel-Cell-Carcinoma-MCC | access-date=22 March 2023 | archive-date=23 March 2023 | archive-url=https://web.archive.org/web/20230323052717/https://www.businesswire.com/news/home/20230322005618/en/Incyte-Announces-FDA-Approval-of-Zynyz%E2%84%A2-retifanlimab-dlwr-for-the-Treatment-of-Metastatic-or-Recurrent-Locally-Advanced-Merkel-Cell-Carcinoma-MCC | url-status=live }}{{cite journal | vauthors = Kang C | title = Retifanlimab: First Approval | journal = Drugs | volume = 83 | issue = 8 | pages = 731–737 | date = June 2023 | pmid = 37184754 | doi = 10.1007/s40265-023-01884-7 | s2cid = 258687035 | url = https://figshare.com/articles/online_resource/Retifanlimab_First_Approval/22698142 }} and in the European Union in April 2024.
Medical uses
Retifanlimab is indicated for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma.{{cite web | title=Drug Approval Package: Zynyz | website=U.S. Food and Drug Administration (FDA) | date=19 April 2023 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761334Orig1s000TOC.cfm | access-date=20 November 2023 | archive-date=20 November 2023 | archive-url=https://web.archive.org/web/20231120062447/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761334Orig1s000TOC.cfm | url-status=dead }}
In May 2025, the US Food and Drug Administration (FDA) expanded the indication for retifanlimab to include, when used with carboplatin and paclitaxel, the first-line treatment of adults with inoperable locally recurrent or metastatic squamous-cell carcinoma of the anal canal. The FDA also approved retifanlimab, as a single agent, for adults with locally recurrent or metastatic squamous-cell carcinoma of the anal canal with disease progression on or intolerance to platinum-based chemotherapy.{{cite web | title=FDA approves retifanlimab-dlwr with carboplatin and paclitaxel and as a single agent for squamous cell carcinoma of the anal canal | website=U.S. Food and Drug Administration (FDA) | date=15 May 2025 | url=https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-retifanlimab-dlwr-carboplatin-and-paclitaxel-and-single-agent-squamous-cell-carcinoma | access-date=16 May 2025}} {{PD-notice}}
Adverse effects
The US Food and Drug Administration (FDA) prescription label for retifanlimab includes warnings and precautions for severe and fatal immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic HSCT, and embryo-fetal toxicity.
History
The US Food and Drug Administration (FDA) evaluated the safety and efficacy of retifanlimab based on PODIUM-201 (NCT03599713), an open-label, multiregional, single-arm study evaluating 65 participants with metastatic or recurrent locally advanced MCC who had not received prior systemic therapy for advanced disease.
The FDA granted the application for retifanlimab priority review, fast track, and orphan drug designations.
The efficacy of retifanlimab with carboplatin and paclitaxel was evaluated in POD1UM-303/InterAACT 2 (NCT04472429), a randomized, multi-center, double-blind trial in 308 participants with chemotherapy-naïve inoperable locally recurrent or metastatic squamous-cell carcinoma of the anal canal. Participants received carboplatin AUC of 5 on day 1, and paclitaxel 80 mg/m{{sup|2}} on days 1, 8, and 15 for 6 cycles and were randomized (1:1) to receive either retifanlimab 500 mg intravenously every 4 weeks; or placebo intravenously every 4 weeks.
The efficacy of retifanlimab as a single agent was evaluated in POD1UM-202 (NCT03597295), an open-label, multi-center, single-arm trial in 94 participants with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy. Participants received retifanlimab 500 mg intravenously every 4 weeks until disease progression, unacceptable toxicity, or up to 24 months.
Society and culture
= Legal status =
In February 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Zynyz, intended for the treatment of Merkel cell carcinoma. The applicant for this medicinal product is Incyte Biosciences Distribution B.V.{{cite web | title=Zynyz EPAR | website=European Medicines Agency (EMA) | date=22 February 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/zynyz | access-date=24 February 2024}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Retifanlimab was authorized for medical use in the European Union in April 2024.
= Names =
Retifanlimab is the international nonproprietary name.{{cite journal | vauthors = ((World Health Organization)) | title = International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83 | journal = WHO Drug Information | volume = 34 | issue = 1 | year = 2020 | hdl = 10665/339768 | hdl-access = free | author-link = World Health Organization }}
References
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External links
- {{ClinicalTrialsGov|NCT03599713|A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201)}}
{{Targeted cancer therapeutic agents}}
{{PD-1_and_PD-L1_inhibitors}}
{{Monoclonals for tumors}}
{{Monoclonals for immune system}}
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