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Entrectinib

Rozlytrek

Extended indication Locally advanced or metastatic solid tumors with NTRK gene fusion in adult and pediatric patients
Therapeutic value No judgement yet
Registration phase Registration application pending

Product

Active substance Entrectinib
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Oncology other
Extended indication Locally advanced or metastatic solid tumors with NTRK gene fusion in adult and pediatric patients
Proprietary name Rozlytrek
Manufacturer Roche
Mechanism of action Tyrosine kinase inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional remarks 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).

Registration

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

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

Expected patient volume per year

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

Expected cost per patient per year

Cost 72,000.00 - 180,000.00
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 remarks 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.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

Off label use No
References Fabrikant

Indication extension

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

Other information

There is currently no futher information available.