Margetuximab

Active substance
Margetuximab
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Breast cancer
Extended indication
Metastatic breast cancer, HER2-positive

1. Product

Manufacturer
MacroGenics
Mechanism of action
Receptor antagonist
Route of administration
Intravenous
Therapeutical formulation
Intravenous drip
Budgetting framework
Intermural (MSZ)
Additional comments
Fabrikant: MacroGenics, ERBB 2 receptor antagonists. Verhoogt de affiniteit voor CD16A-polymorfismen en verlaagt de affiniteit voor FcyRIIB (CD32B), een remmende receptor.

2. Registration

Registration route
Centralised (EMA)
Submission date
2020
Expected Registration
2021
Orphan drug
No
Registration phase
Clinical trials

3. Therapeutic value

Therapeutic value
No judgement
Duration of treatment
Not found
Frequency of administration
1 times every 3 weeks
Dosage per administration
15 mg/kg
References
NCT02492711

4. Expected patient volume per year

References
NKR 2015 en 2016
Additional comments
Er zijn 1958 HER2+ patiënten met mammacarcinoom (zo'n 12% van alle patiënten met mammacarcinoom). Minder dan 200 patiënten betreft stadium 4 mammacarcinoom. Het gaat echter om een tweede / derdelijns behandeling. Afhankelijk van de studieresultaten zal een subgroep van de patiënten die in de tweede / derde lijn worden behandeld in aanmerking komen voor dit geneesmiddel.

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
Yes
Indication extensions
Gastric cancer; Oesophageal cancer
References
Clinicaltrials.gov, AdisInsight
Additional comments
lopende fase III studies

9. Other information

There is currently no futher information available.