Trastuzumab deruxtecan

Active substance
Trastuzumab deruxtecan
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Breast cancer
Extended indication
Treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 therapies.

1. Product

Proprietary name
Enhertu
Manufacturer
Daiichi Sankyo
Mechanism of action
Antibody-drug conjugate
Route of administration
Intravenous
Therapeutical formulation
Intravenous drip
Budgetting framework
Intermural (MSZ)

2. Registration

Registration route
Centralised (EMA)
Submission date
July 2020
Expected Registration
August 2021
Orphan drug
No
Registration phase
Clinical trials

3. Therapeutic value

Current treatment options
No standard of care: lapatinib + chemo or trastuzumab +/- pertuzumab +/- chemo or hormone therapy or T-DM1.
Therapeutic value
No judgement
Substantiation
Op dit moment is er een vergelijkende studie ten opzichte van T-DM1 ( NCT03529110). Resultaten zullen bekend zijn in 2022.
Duration of treatment
Median 11.1 month / months
Frequency of administration
1 times every 3 weeks
Dosage per administration
5,4 mg/kg
References
NCT03248492;NCT03523585; NCT03529110

4. Expected patient volume per year

Patient volume

< 242

Market share is generally not included unless otherwise stated.

References
NKR; Seven-Year Follow-Up Analysis of Adjuvant Paclitaxel and Trastuzumab Trial for Node-Negative, Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer Sara M. Tolaney. Journal of Clinical Oncology 2019 37:22, 1868-1875; vektis.
Additional comments
De verwachting is dat indien trastuzumab deruxtecan effectiever blijkt te zijn dan T-DM1 de patiëntpopulatie zal overstappen. Op dit moment zijn er 242 patiënten welke T-DM1 ontvangen voor de huidige indicatie.

5. Expected cost per patient per year

Cost
135,000
References
https://www.fiercepharma.com/special-report/1-enhertu
Additional comments
Op basis van de Amerikaanse verwachte prijs: €13,300 per maand. Uitgaande van 11,1 maanden zou dat neerkomen op €147,630, en zo'n 135.000.

6. Potential total cost per year

Total cost

32,670,000

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.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

Indication extension
Yes
Indication extensions
Treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2 therapies. Treatment of adult patients with unresectable or metastatic HER2-Low breast cancer.
References
fabrikant

9. Other information

There is currently no futher information available.