Extended indication Patients with HER2 low, unresectable, and/or metastatic breast cancer previously treated with 1-2 pr
Therapeutic value No judgement yet
Registration phase Clinical trials

Product

Active substance Trastuzumab deruxtecan
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Breast cancer
Extended indication Patients with HER2 low, unresectable, and/or metastatic breast cancer previously treated with 1-2 prior lines of chemotherapy
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)
Additional remarks HER2-low population in this trial including tumors with IHC 1+ and IHC 2+/ISH- HER2 expression Patients in study progressed on, and would no longer benefit from endocrine therapy and have been treated with 1 or 2 prior chemotherapy/ adjuvant in the metastatic setting

Registration

Registration route Centralised (EMA)
Submission date October 2021
Expected Registration 2022
Registration phase Clinical trials
Additional remarks Fabrikant verwacht indiening in H2 2021 en registratie in 2022.

Therapeutic value

Therapeutic value No judgement yet
Substantiation De DESTINY-Breast04 studie loopt op dit moment nog.
Frequency of administration 1 times every 3 weeks
Dosage per administration 5,4mg/kg
References DB-04 (NCT03734029)

Expected patient volume per year

Additional remarks Het is op dit moment nog niet mogelijk in te schatten hoeveel patiƫnten van deze nieuwe populatie er in aanmerking zullen komen.

Expected cost per patient per year

References https://www.fiercepharma.com/special-report/1-enhertu
Additional remarks 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 ER2-overexpressing advanced gastric or gastroesophageal junction adenocarcinoma patients who have progressed on two prior treatment regimens (NCT03329690)
References Fabrikant

Other information

There is currently no futher information available.