Margetuximab Medicine 10 December 2019 Extended indication Metastatic breast cancer, HER2-positive Therapeutic value No judgement Total cost 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 Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer MacroGenics Portfolio holder Mechanism of action Receptor antagonist Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks 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) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2020 Expected Registration 2021 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 15 mg/kg References NCT02492711 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2015 en 2016 Additional remarks 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. Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Gastric cancer; Oesophageal cancer References Clinicaltrials.gov, AdisInsight Additional remarks lopende fase III studies Other information Additional remarks