Trastuzumab deruxtecan

Enhertu
Active substance

Trastuzumab deruxtecan
Domain

Oncology and Hematology
Reason of inclusion

Indication extension
Main indication

Breast cancer
Extended indication 
Treatment of adult patients with Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane 2L.

Product
Proprietary name

Enhertu
Manufacturer

Daiichi Sankyo
Mechanism of action

Antibody-drug conjugate
Route of administration

Intravenous
Therapeutical formulation

Injection / infusion solution
Budgetting framework

Intermural (MSZ)

Registration
Registration route

Centralised (EMA)
Type of trajectory

Normal trajectory
Submission date

October 2021
Expected Registration

2022
Orphan drug

No
Registration phase

Clinical trials
Additional comments 
De fabrikant verwacht indiening in 2e helft 2021 en registratie in 2022.

Therapeutic value
Current treatment options

Trastuzumab-emtansine
Therapeutic value

No judgement yet
Substantiation

Op dit moment loopt de DESTINY-Breast03 studie nog.
Duration of treatment

Average 10 month / months
Frequency of administration

1 times every 3 weeks
Dosage per administration

5,4mg/kg
References 
DESTINY-Breast03 (NCT03529110)
Additional comments 
Dit betreft dezelfde populatie als geneesmiddel 1 (op basis van DB-01/DB-02), maar dan in een lijn eerder. Deze indicatie zal naar verwachting gebruik in de derde lijn sterk doen afnemen.

Expected patient volume per year
Patient volume

< 285

Market share is generally not included unless otherwise stated.
References 
NKR 2016; record Trastuzumab emtansine; GIPdatabank.
Additional comments 
Patiënten die nu in de tweede lijn trastuzumab emtansine ontvangen zullen in aanmerking komen. Dit waren in totaal 285 patiënten in 2019. Een gedeelte hiervan komt mogelijk in aanmerking voor behandeling met trastuzumab deruxtecan.

Expected cost per patient per year
Cost

€ 110,000.00
References 
https://www.fiercepharma.com/special-report/1-enhertu
Additional comments 
Op basis van de Amerikaanse verwachte prijs: $13,300 per maand. Uitgaande van 10 maanden zou dat neerkomen op $133,000, en zo'n €110.000. De prijs in Nederland is nog niet bepaald.

Potential total cost per year
Total cost

€ 31,350,000

This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

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-Low breast cancer. Treatment of ER2-overexpressing advanced gastric or gastroesophageal junction adenocarcinoma patients who have progressed on two prior treatment regimens (NCT03329690).
References 
Fabrikant

Other information

There is currently no futher information available.