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]
| 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 |
It was approved for medical use in the United States in March 2023.[1][2][3][4][5]
Medical uses
Retifanlimab is indicated for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma.[1][2][6]
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.[2]
The FDA granted the application for retifanlimab priority review, fast track, and orphan drug designations.[2]
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.[7] The applicant for this medicinal product is Incyte Biosciences Distribution B.V.[7]
Names
Retifanlimab is the international nonproprietary name.[8]
References
External links
- Clinical trial number NCT03599713 for "A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201)" at ClinicalTrials.gov
