Cusatuzumab

Therapeutic value No judgement
Total cost
Registration phase Clinical trials
ATMP Unknown

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 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

October 2020

Expected Registration

December 2021

Registration phase

Clinical trials

Additional comments
Fabrikant verwacht registratie in Q4 2020 of Q1 2021.

Therapeutic value

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

Off label use

Yes

Indications off label use

Geen indicatie-uitbreidingen op korte termijn. Wel in fase I/II voor: "Cutaneous T-cell lymphoma Haematological malignancies; Myelodysplastic syndromes; Solid tumours".

Indication extension

Indication extension

No

References
clinicaltrials.gov

Other information

There is currently no futher information available.