Trastuzumab deruxtecan

Active substance

Trastuzumab deruxtecan


Oncology and Hematology

Reason of inclusion

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.


Proprietary name



Daiichi Sankyo

Mechanism of action

Antibody-drug conjugate

Route of administration


Therapeutical formulation

Intravenous drip

Budgetting framework

Intermural (MSZ)


Registration route

Centralised (EMA)

Submission date

July 2020

Expected Registration

August 2021

Orphan drug


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


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

NCT03248492;NCT03523585; NCT03529110

Expected patient volume per year

Patient volume

< 242

Market share is generally not included unless otherwise stated.

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



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


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


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.


Other information

There is currently no futher information available.