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.

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)

Registration

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

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

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.

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.

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.

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 one or more prior anti-HER2 therapies. Treatment of adult patients with unresectable or metastatic HER2-Low breast cancer.
References fabrikant

Other information

There is currently no futher information available.