Extended indication Patients with HER2 low, unresectable, and/or metastatic breast cancer previously treated with 1-2 pr
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 Breast cancer
Extended indication Patients with HER2 low, unresectable, and/or metastatic breast cancer previously treated with 1-2 prior lines of chemotherapy in the metastatic setting and has progressed on, and would no longer benefit from, endocrine therapy.
Proprietary name Enhertu
Manufacturer AstraZeneca
Mechanism of action Antibody-drug conjugate
Route of administration Intravenous
Therapeutical formulation Injection / infusion solution
Budgetting framework Intermural (MSZ)
Additional comments 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)
ATMP No
Submission date February 2022
Expected Registration December 2022
Orphan drug No
Registration phase Clinical trials
Additional comments Fabrikant verwacht indiening in de eerste helft van 2022 en registratie in het vierde kwartaal van 2022/eerste helft van 2023.

Therapeutic value

Therapeutic value No estimate possible 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 comments 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 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

References Fabrikant

Other information

There is currently no futher information available.