Extended indication Treatment of ER2-overexpressing advanced gastric or gastroesophageal junction adenocarcinoma patient
Therapeutic value No estimate possible yet
Registration phase Clinical trials

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 AstraZeneca
Mechanism of action Antibody-drug conjugate
Route of administration Intravenous
Therapeutical formulation Injection / infusion solution
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
ATMP No
Submission date 2021
Expected Registration 2022
Orphan drug No
Registration phase Clinical trials
Additional comments De fabrikant verwacht registratie in de eerste helft van 2022.

Therapeutic value

Therapeutic value No estimate possible yet
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

Indication extension Yes
Indication extensions Treatment of adult patients with unresectable or metastatic HER2-Low breast cancer.

Other information

There is currently no futher information available.