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Trastuzumab deruxtecan

Enhertu

Extended indication

Treatment of ER2-overexpressing advanced gastric or gastroesophageal junction adenocarcinoma patient

Therapeutic value

No judgement
Registration phase

Registration application pending

Product

Active substance

Trastuzumab deruxtecan
Domain

Oncology and Hematology
Reason of inclusion

Indication extension
Main indication

Stomach cancer
Extended indication

Treatment of ER2-overexpressing advanced gastric or gastroesophageal junction adenocarcinoma patients who have progressed on two prior treatment regimens
Proprietary name

Enhertu
Manufacturer

Daiichi Sankyo
Mechanism of action

Antibody-drug conjugate
Route of administration

Intravenous
Therapeutical formulation

Injection / infusion solution
Budgetting framework

Intermural (MSZ)

Registration

Registration route

Centralised (EMA)
Submission date

October 2020
Expected Registration

2022
Orphan drug

No
Registration phase

Registration application pending
Additional comments 
De fabrikant verwacht registratie in 2022.

Therapeutic value

Therapeutic value

No judgement
Substantiation

Op dit moment loopt de DESTINY-Gastric02 studie nog.
Frequency of administration

1 times every 3 weeks
Dosage per administration

6,4mg/kg

Expected patient volume per year

Patient volume

< 78

Market share is generally not included unless otherwise stated.
References 
IKNL; expertopinie; Record rivoceranib
Additional comments 
Ongeveer 70 patiënten worden behandeld in de tweede lijn voor gemetastaseerd adenocarcinoom van de maag of gastro-oesofageale overgang. Het aantal patiënten met een slokdarmcarcinoom die in de tweede lijn worden behandeld bedraagt ongeveer 60. In totaal zijn dit dus 130 patiënten. De inschatting is dat hiervan maximaal 60% een derdelijns behandeling krijgt (78 patiënten).

Expected cost per patient per year

References 
https://www.fiercepharma.com/special-report/1-enhertu
Additional comments 
Op basis van de Amerikaanse verwachte prijs: $13,300 per maand.

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.