Expand all sections

Trastuzumab deruxtecan

Enhertu

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 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)
ATMP

No
Submission date

2022
Expected Registration

2023
Orphan drug

No
Registration phase

Clinical trials
Additional remarks 
Fabrikant verwacht indiening in de eerste helft van 2022 en registratie in de 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 remarks 
Het is op dit moment nog niet mogelijk in te schatten hoeveel patiënten 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
References 
Fabrikant

Other information

There is currently no futher information available.