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)

1. 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.

2. Registration

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

3. 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

4. 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.

5. Expected cost per patient per year

There is currently nothing known about the expected cost.

6. Potential total cost per year

There is currently nothing known about the possible total cost.

7. Off label use

There is currently nothing known about off label use.

8. 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".

9. Other information

There is currently no futher information available.