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.