Loading AI tools
Medication From Wikipedia, the free encyclopedia
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]
Retifanlimab is indicated for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma.[1][2][6]
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]
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]
Retifanlimab is the international nonproprietary name.[8]
Seamless Wikipedia browsing. On steroids.
Every time you click a link to Wikipedia, Wiktionary or Wikiquote in your browser's search results, it will show the modern Wikiwand interface.
Wikiwand extension is a five stars, simple, with minimum permission required to keep your browsing private, safe and transparent.