Retifanlimab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized |
| Target | Programmed cell death protein 1 (PD-1) |
| Clinical data | |
| Trade names | Zynyz |
| Other names | AEX-1188, INCMGA-00012, MGA-012, retifanlimab-dlwr |
| AHFS/Drugs.com | Zynyz |
| MedlinePlus | a623017 |
| License data |
|
| Routes of administration | Intravenous |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6456H9934N1702O2032S46 |
| Molar mass | 145381.13 g·mol−1 |
Retifanlimab, sold under the brand name Zynyz, is an anti-cancer medication used for the treatment of Merkel cell carcinoma.[1] Retifanlimab is a programmed death receptor-1 (PD-1)–blocking monoclonal antibody.[1]
It was approved for medical use in the United States in March 2023.[1][2][3][4][5]
Medical uses
[edit]Retifanlimab is indicated for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma.[1][2][6]
History
[edit]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.[2]
The FDA granted the application for retifanlimab priority review, fast track, and orphan drug designations.[2]
Society and culture
[edit]Legal status
[edit]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.[7] The applicant for this medicinal product is Incyte Biosciences Distribution B.V.[7]
Names
[edit]Retifanlimab is the international nonproprietary name.[8]
References
[edit]- ^ a b c d e "Zynyz- retifanlimab-dlwr injection". DailyMed. 22 March 2023. Archived from the original on 1 July 2023. Retrieved 20 November 2023.
- ^ a b c d "FDA grants accelerated approval to retifanlimab-dlwr for metastatic or recurrent locally advanced Merkel cell carcinoma". U.S. Food and Drug Administration (FDA). 22 March 2023. Archived from the original on 23 March 2023. Retrieved 22 March 2023.
This article incorporates text from this source, which is in the public domain.
- ^ "Incyte Announces FDA Approval of Zynyz (retifanlimab-dlwr) for the Treatment of Metastatic or Recurrent Locally Advanced Merkel Cell Carcinoma (MCC)" (Press release). Incyte. 22 March 2023. Archived from the original on 23 March 2023. Retrieved 22 March 2023 – via Business Wire.
- ^ "MacroGenics Earns $15 Million Milestone Following U.S. FDA Approval of Zynyz (retifanlimab-dlwr)" (Press release). MacroGenics. 22 March 2023. Archived from the original on 23 March 2023. Retrieved 22 March 2023 – via GlobeNewswire.
- ^ Kang C (June 2023). "Retifanlimab: First Approval". Drugs. 83 (8): 731–737. doi:10.1007/s40265-023-01884-7. PMID 37184754. S2CID 258687035.
- ^ "Drug Approval Package: Zynyz". U.S. Food and Drug Administration (FDA). 19 April 2023. Archived from the original on 20 November 2023. Retrieved 20 November 2023.
- ^ a b "Zynyz EPAR". European Medicines Agency (EMA). 22 February 2024. Retrieved 24 February 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information. 34 (1). hdl:10665/339768.
External links
[edit]- Clinical trial number NCT03599713 for "A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201)" at ClinicalTrials.gov
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