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Enhertu
Treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 therapies.
No judgement
€ 26,620,000.00
Registration application pending
Trastuzumab deruxtecan
Oncology and Hematology
New medicine (specialité)
Breast cancer
Daiichi Sankyo
Antibody-drug conjugate
Intravenous
Intravenous drip
Intermural (MSZ)
Centralised (EMA)
Accelerated assessment
June 2020
February 2021
No
Fabrikant verwacht registratie in februari 2021.
No standard of care: lapatinib + chemo or trastuzumab +/- pertuzumab +/- chemo or hormone therapy or T-DM1.
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.
€ 110,000.00
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.
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.
Understanding of expected market entry of innovative medicines