Is Retifanlimab approved by the US FDA?

Drugs@FDA lists 1 application product line for Retifanlimab, including ZYNYZ (Prescription).

Is Retifanlimab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Retifanlimab: Zynyz.

Are there safety signals or safety updates for Retifanlimab?

EMA PRAC: 5 entries; US FDA: 1 entry (latest 2026-06-11).

Active substance

Retifanlimab

US FDA 1
EMA 2
Health Canada 1
Safety 6

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
ZYNYZ	500MG/20ML(25MG/ML)	injectable · intravenous	INCYTE CORP	Prescription	22 Mar 2023

EMA European Union — centrally authorised medicines

Zynyz Incyte Biosciences Distribution B.V. · Authorised · authorised 19 Apr 2024 · ATC L01FF10

Therapeutic indication (EMA)

Squamous cell carcinoma of the anal canal (SCAC) Zynyz is indicated in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC). Merkel cell carcinoma (MCC) Zynyz is indicated as monotherapy for the first line treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) not amenable to curative surgery or radiation therapy.

Zynyz Incyte Biosciences Distribution B.V. · Application withdrawn · ATC L01FX06

Therapeutic indication (EMA)

Treatment of locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) who have progressed on or who are intolerant of platinum-based chemotherapy

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ZYNYZ	02555239	25 MG / ML	SOLUTION · INTRAVENOUS	INCYTE CORPORATION

Safety signals and safety-related labeling changes

EMA PRAC 11 Jun 2026 PRAC signal: Acquired haemophilia
Action for MAH: update of the product information: No
US FDA 18 May 2026 ZYNYZ — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 10 Apr 2025 PRAC signal: Scleroderma, systemic scleroderma, morphea
Action for MAH: update of the product information: No
EMA PRAC 16 Jan 2025 PRAC signal: Thrombotic microangiopathy
Action for MAH: update of the product information: No
EMA PRAC 31 Oct 2024 PRAC signal: Scleroderma, systemic scleroderma, morphea
Action for MAH: update of the product information: No
EMA PRAC 11 Jul 2024 PRAC signal: Thrombotic microangiopathy
Action for MAH: update of the product information: No

All safety entries for retifanlimab →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.