Extended indication Metastatic breast cancer, HER2-positive.
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

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

Registration

Registration route Centralised (EMA)
Submission date 2021
Expected Registration 2022
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Therapeutic value No estimate possible yet
Frequency of administration 1 times every 3 weeks
Dosage per administration 15 mg/kg
References NCT02492711

Expected patient volume per year

Patient volume

100 - 200

Market share is generally not included unless otherwise stated.

References NKR 2018.
Additional comments Er waren 2.060 HER2+ patiënten met mammacarcinoom in 2018. Zo'n 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. Inschatting 100-200 patiënten.

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 Yes
Indication extensions Gastric cancer; Oesophageal cancer.
References Clinicaltrials.gov, AdisInsight.
Additional comments Lopende fase 3 studies.

Other information

There is currently no futher information available.