Extended indication

Acute myeloïde leukemie (AML)

Therapeutic value

No judgement

Registration phase

Clinical trials

Product

Active substance

Cusatuzumab

Domain

Oncology and Hematology

Reason of inclusion

New medicine (specialité)

Main indication

AML / MDS

Extended indication

Acute myeloïde leukemie (AML)

Proprietary name

ARGX-110

Manufacturer

Janssen

Mechanism of action

Other

Route of administration

Intravenous

Therapeutical formulation

Intravenous drip

Budgetting framework

Intermural (MSZ)

Additional remarks
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

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 remarks
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.