Entrectinib

Active substance
Entrectinib
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
Indication extension
Main indication
Other oncology
Extended indication
Locally advanced or metastatic solid tumors with NTRK gene fusion in adult and pediatric patients

1. Product

Proprietary name
Rozlytrek
Manufacturer
Roche
Mechanism of action
Tyrosine kinase inhibitor
Route of administration
Oral
Therapeutical formulation
Tablet
Budgetting framework
Intermural (MSZ)
Additional comments
Inhibitor of the tyrosine kinases TrkA (coded by the gene NTRK1), TrkB (coded by the gene NTRK2), TrkC (coded by the gene NTRK3), ROS1 (coded by the gene ROS1), and ALK (coded by the gene ALK).

2. Registration

Registration route
Centralised (EMA)
Submission date
January 2019
Expected Registration
August 2020
Orphan drug
No
Registration phase
Registration application pending
Additional comments
Verwachte registratie volgens fabrikant in derde kwartaal van 2020.

3. Therapeutic value

Current treatment options
Afhankelijk van tumor type en in de toekomst larotrectinib
Therapeutic value
No judgement yet
Duration of treatment
Not found
Frequency of administration
1 times a day
Dosage per administration
600 mg
References
Fabrikant

4. Expected patient volume per year

Additional comments
Nog niet bekend, afhankelijk van specifieke indicatie en studieresultaten.

5. Expected cost per patient per year

Cost
72,000 - 180,000
References
https://www.reuters.com/article/us-roche-hldg-fda-pricing/roche-cancer-treatment-priced-at-17050-a-month-lower-than-rival-vitrakvi-idUSKCN1V61G8; fabrikant
Additional comments
De lijstprijs voor entrectinib in de Verenigde Staten is gesteld op $17,050 per maand (ongeveer €15.000). Dit is ongeveer de helft van de prijs van concurrent larotrectinib (Bayer). Op jaarbasis bij behandeling van 12 maanden zou dit neerkomen op €180.000. Naar verwachting zal in Europa prijs wat lager liggen. De fabrikant verwacht €72.000 per patiënt per jaar op basis van 12 maanden behandeling.

6. Potential total cost per year

There is currently nothing known about the possible total cost.

7. Off label use

Off label use
No
References
Fabrikant

8. Indication extension

Indication extension
Yes
Indication extensions
Patiënten ROS1-positief geavanceerde of gemetastaseerde NSCLC
References
Fabrikant

9. Other information

There is currently no futher information available.