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Entrectinib

Extended indication Patiënten met geavanceerde of gemetastaseerde tumoren met NTRK+ na eerdere behandeling of bij geen b
Therapeutic value No judgement yet
Registration phase Clinical trials

Product

Active substance Entrectinib
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Oncology other
Extended indication Patiënten met geavanceerde of gemetastaseerde tumoren met NTRK+ na eerdere behandeling of bij geen beschikbare alternatieve behandelopties
Manufacturer Roche
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Extramural (GVS)
Additional remarks Mechanism of action (AdisInsight): "Anaplastic lymphoma kinase inhibitors; ROS1-protein-inhibitors; TrkA receptor antagonists; TrkB receptor antagonists; TrkC receptor antagonists".

Registration

Registration route Centralised (EMA)
Submission date October 2018
Expected Registration September 2019
Registration phase Clinical trials
Additional remarks Fabrikant: "Er is nog veel onzekerheid over de precieze registratie procedure voor entrectinib".

Therapeutic value

Current treatment options Larotrectinib
Therapeutic value No judgement yet
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

References Fabrikant
Additional remarks Er is nog niets bekend over de prijs van entrectinib

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.