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Trastuzumab duocarmazine

Extended indication in 3e lijn gemetastaseerd borstkanker HER2+.
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance Trastuzumab duocarmazine
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Breast cancer
Extended indication in 3e lijn gemetastaseerd borstkanker HER2+.
Manufacturer Synthon
Mechanism of action Receptor antagonist
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Fabrikant: Synthon. ERBB 2 receptor antagonists.

Registration

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

Therapeutic value

Therapeutic value No judgement
Frequency of administration 1 times every 3 weeks
Dosage per administration 6 mg/kg
References NCT03262935

Expected patient volume per year

Patient volume

100 - 120

Market share is generally not included unless otherwise stated.
References NKR 2015 en 2016
Additional remarks Er zijn 1.958 HER2+ patiënten met mammacarcinoom (zo'n 12% van alle patiënten met mammacarcinoom). Minder dan 200 patiënten betreft stadium 4 mammacarcinoom. Per additionele lijn mogelijk zo'n 20%-25% van de patiënten minder (80-100 patiënten). Dit zou naar schatting uitkomen op zo'n 100-120 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 No
References Clinicaltrials.gov, AdisInsight.
Additional remarks Geen andere fase 3 studies op dit moment.

Other information

There is currently no futher information available.