Trastuzumab deruxtecan

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.

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)

Type of trajectory

Accelerated assessment

Submission date

June 2020

Expected Registration

February 2021

Orphan drug

No

Registration phase

Registration application pending

Additional comments
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 comments
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 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

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

26,620,000

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 (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.