Retifanlimab

Retifanlimab, sold under the brand name Zynyz, is an anti-cancer medication used for the treatment of Merkel cell carcinoma.^[2] Retifanlimab is a programmed death receptor-1 (PD-1)–blocking monoclonal antibody.^[2]

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	US DailyMed: Retifanlimab
Routes of administration	Intravenous
ATC code	L01FF10 (WHO)
Legal status
Legal status	CA: ℞-only[1] US: ℞-only[2]
Identifiers
CAS Number	2079108-44-2
DrugBank	DB15766
UNII	2Y3T5IF01Z
KEGG	D11827
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.^{[2][3][4][5][6]}

Medical uses

Retifanlimab is indicated for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma.^[2][3][7]

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.^[3]

The FDA granted the application for retifanlimab priority review, fast track, and orphan drug designations.^[3]

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.^[8] The applicant for this medicinal product is Incyte Biosciences Distribution B.V.^[8]

Names

Retifanlimab is the international nonproprietary name.^[9]