Trastuzumab deruxtecan

Oncology and Hematology

New medicine (specialité)

Breast cancer

Treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 therapies.

Enhertu

Daiichi Sankyo

Antibody-drug conjugate

Intravenous

Intravenous drip

Intermural (MSZ)

Centralised (EMA)

Accelerated assessment

June 2020

February 2021

No

Registration application pending

Fabrikant verwacht registratie in februari 2021.

No standard of care: lapatinib + chemo or trastuzumab +/- pertuzumab +/- chemo or hormone therapy or T-DM1.

No judgement

Op dit moment is er een vergelijkende studie ten opzichte van T-DM1 ( NCT03529110). Resultaten zullen bekend zijn in 2022.

Median 10 month / months

1 times every 3 weeks

5,4 mg/kg

NCT03248492;NCT03523585; NCT03529110

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.

< 242

Market share is generally not included unless otherwise stated.

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.

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.

https://www.fiercepharma.com/special-report/1-enhertu

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.

€ 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.

There is currently nothing known about off label use.

Yes

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)

fabrikant

There is currently no futher information available.