Cusatuzumab

Active substance Cusatuzumab
Domain Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen New medicine (specialité)
Main indication AML / MDS
Extended indication Acute myeloïde leukemie (AML)

Product

Proprietary name ARGX-110
Manufacturer Janssen
Mechanism of action Other
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional comments Cusatuzumab is ontworpen om: CD70 te blokkeren en kankercellen die CD70 tot expressie brengen te doden door: complementafhankelijke cytotoxiciteit, verbeterde antilichaamafhankelijke celgemedieerde fagocytose en verbeterde antilichaamafhankelijke celgemedieerde cytotoxiciteit en het herstel van het immuunsysteem tegen solide tumoren.

Registration

Registration route Centralised (EMA)
Submission date April 2021
Expected Registration April 2022
Registration phase Clinical trials

Therapeutic value

Therapeutic value No judgement
Duration of treatment Not found
Frequency of administration 2 times every 4 weeks
Dosage per administration 10mg/kg - 20 mg/kg
References NCT04023526

Expected patient volume per year

Patient volume

< 774

Market share is generally not included unless otherwise stated.

References NKR
Additional comments In 2017 waren er 774 patiënten met AML.

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension No
References Geen indicatie-uitbreidingen op korte termijn. Wel in fase I/II voor: "Cutaneous T-cell lymphoma Haematological malignancies; Myelodysplastic syndromes; Solid tumours".

Other information

There is currently no futher information available.