Trastuzumab duocarmazine

Active substance
Trastuzumab duocarmazine
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Breast cancer
Extended indication
in 3e lijn gemetastaseerd borstkanker HER2+

1. Product

Manufacturer
Synthon
Mechanism of action
Receptor antagonist
Route of administration
Intravenous
Therapeutical formulation
Intravenous drip
Budgetting framework
Intermural (MSZ)
Additional comments
Fabrikant: Synthon. ERBB 2 receptor antagonists.

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
6 mg/kg
References
NCT03262935

4. Expected patient volume per year

Patient volume

100 - 120

Market share is generally not included unless otherwise stated.

References
NKR 2015 en 2016
Additional comments
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.

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
No
References
Clinicaltrials.gov, AdisInsight
Additional comments
geen andere fase 3 studies op dit moment.

9. Other information

There is currently no futher information available.