Entrectinib Medicine 13 December 2018 Extended indication Patiënten met geavanceerde of gemetastaseerde tumoren met NTRK+ na eerdere behandeling of bij geen beschikbare alternatieve behandelopties Therapeutic value No judgement yet Total cost 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 Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Roche Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Capsule Budgetting framework Extramural (GVS) Centre of expertise 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) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date October 2018 Expected Registration September 2019 Orphan drug Unknown Registration phase Clinical trials Reimbursement Medicine sluice 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 This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times a day Dosage per administration 600 mg References Fabrikant Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Nog niet bekend, afhankelijk van specifieke indicatie en studieresultaten. Expected cost per patient per year Cost References Fabrikant Additional remarks Er is nog niets bekend over de prijs van entrectinib Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Fabrikant Additional remarks Indication extension Indication extensions Yes Indication extensions Patiënten ROS1-positief geavanceerde of gemetastaseerde NSCLC References Fabrikant Additional remarks Other information Additional remarks