Extended indication Solid tumours - with NTRK1, NTRK2 or NTRK3 gene fusion.
Therapeutic value Possible added value
Registration phase Clinical trials

Product

Active substance Larotrectinib
Domain Oncology and Hematology
Main indication Oncology other
Extended indication Solid tumours - with NTRK1, NTRK2 or NTRK3 gene fusion.
Manufacturer Bayer
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)
Additional remarks Locally advanced or metastatic solid tumors with NTRK gene fusion in adult and pediatric patients.

Registration

Registration route Centralised (EMA)
Particularity New medicine
Submission date 2018
Expected Registration May 2019
Orphan drug No
Registration phase Clinical trials
Additional remarks In de VS wel een orphan drug status.

Therapeutic value

Current treatment options Afhankelijk van het tumortype.
Therapeutic value Possible added value
Substantiation De Fase I/II studie van Drilon et al. laat veelbelovende resultaten zien.
References Drilon et al. N Engl J Med 2018; 378:731-739; NCT02637687; NCT02576431
Additional remarks Fase I voor volwassen patiënten, fase 1/2 voor pediatrische patiënten (SCOUT), fase 2 voor volwassenen en adolescenten (NAVIGATE).

Expected patient volume per year

Patient volume

100 - 300

Market share is generally not included unless otherwise stated.

References NKR; Stransky et al. Nat Commun. 2014 Sep 10; 5: 4846
Additional remarks Er worden per jaar ongeveer 100.000 solide tumoren gediagnosticeerd. Incidentie van NTKR fusies bedraagt ongeveer 0,3%. Dit zou een populatie van 300 patiënten bedragen met een NTKR-fusie. De werkgroep schat het patiëntvolume in op ongeveer 100.

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.