Expand all sections

Trastuzumab deruxtecan

Enhertu

Extended indication Extension of indication to include treatment of unresectable or metastatic HER2-low (IHC 1+ or IHC 2
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Trastuzumab deruxtecan
Domain Oncology
Reason of inclusion Indication extension
Main indication Breast cancer
Extended indication Extension of indication to include treatment of unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or withing 6 months of completing adjuvant chemotherapy. Patients with hormone receptor positive (HR+) breast cancer must additionally have received or be ineligible for 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 June 2022
Expected Registration July 2023
Orphan drug No
Registration phase Registration application pending
Additional remarks Fabrikant verwacht indiening in de eerste helft van 2022 en registratie in de eerste helft van 2023.

Therapeutic value

Current treatment options SoC chemotherapie
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). Modi et al. N Engl J Med 2022; 387:9-20.

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 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.