Entrectinib

Active substance
Entrectinib
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Lung cancer
Extended indication
Patiënten ROS1-positief geavanceerde of gemetastaseerde NSCLC

1. Product

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)
Type of trajectory
Normal trajectory
Submission date
January 2019
Expected Registration
January 2020
Registration phase
Registration application pending

3. Therapeutic value

Current treatment options
Crizotinib
Therapeutic value
No judgement yet
Duration of treatment
Not found
Frequency of administration
1 times a day
Dosage per administration
600mg
References
Fabrikant; clinicaltrials.gov and Doebele et al. 2018 (IASLC)

4. Expected patient volume per year

Patient volume

50

Market share is generally not included unless otherwise stated.

References
NKR; Bubendorf, et al., Virchows Arch. 2016; 469(5): 489–503., Epskamp PALGA/ pulmoscript 2015, expertopinie.
Additional comments
Jaarlijks presenteren er ongeveer 7.500 patiënten per jaar met NSCLC stadium IIIb/IV. 1-2% van alle NSCLC patiënten is ROS1 positief (75-150). Gezien maar 25% van de patienten getest wordt op ROS1 is de verwachting dat het aantal patiënten in de praktijk lager zal zijn. Van alle tumoren met wildtype EGFR/KRAS wordt 50% getest op ROS1. Patiëntvolume zal dan ook voorlopig lager zijn, verwachting rond de 50 patiënten.

5. Expected cost per patient per year

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

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
NTRK+
References
Fabrikant

9. Other information

There is currently no futher information available.