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
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 2022
Expected Registration 2023
Orphan drug No
Registration phase Clinical trials
Additional comments 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 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 De verwachte prijs in de Verenigde Staten is: $13,300 per maand. De prijs in Nederland is nog niet bepaald.

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 positive breast cancer who have received two or more prior anti HER2 based regimens (NCT03248492). Treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2therapies (2L) (NCT03529110). Treatment of HER2-overexpressing advanced gastric or gastroesophageal junction adenocarcinoma patients who have progressed on two prior treatment regimens (NCT03329690). Treatment of adult patients with HER2-mutated, Unresectable and/or Metastatic non-small cell lung cancer (NSCLC) (NCT03505710).
References Fabrikant

Other information

There is currently no futher information available.