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Trastuzumab deruxtecan

Enhertu

Extended indication Treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have rec
Therapeutic value No judgement
Total cost 26,620,000.00
Registration phase Registration application pending

Product

Active substance Trastuzumab deruxtecan
Domain 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 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)
Type of trajectory Accelerated assessment
Submission date June 2020
Expected Registration February 2021
Orphan drug No
Registration phase Registration application pending
Additional remarks Fabrikant verwacht registratie in februari 2021.

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 10 month / months
Frequency of administration 1 times every 3 weeks
Dosage per administration 5,4 mg/kg
References NCT03248492;NCT03523585; NCT03529110
Additional remarks Gemiddelde behandelduur is op basis van fase 2 studie. Fase 3 is nog lopend. De huidige registratie aanvraag is gebaseerd op fase 2 onderzoek (DB-01). EMA update op basis van fase 3 3L wordt in het vierde kwartaal van 2022 verwacht.

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 remarks 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 110,000.00
References https://www.fiercepharma.com/special-report/1-enhertu
Additional remarks 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

26,620,000.00

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 (2L) (NCT03529110). 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.