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Pexidartinib

Extended indication Pigmented villo-nodular synovitis (PVNS) and giant cell tumour of tendon sheath
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance Pexidartinib
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Oncology other
Extended indication Pigmented villo-nodular synovitis (PVNS) and giant cell tumour of tendon sheath
Manufacturer Plexxikon
Route of administration Oral
Therapeutical formulation Capsule
Additional remarks CFS1R tyrosine kinase remmer.

Registration

Registration route Centralised (EMA)
Expected Registration October 2019
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Therapeutic value No judgement
Substantiation ENLIVEN trial shows reduced tumor size.
Frequency of administration 5 times a day
Dosage per administration 200 mg
References NCT02371369
Additional remarks Patiënten ontvangen 1000 mg (5 capsules per dag) gedurende 2 weken, daarna 800 mg (4 capsules per dag) gedurende 22 weken.

Expected patient volume per year

Patient volume

30 - 50

Market share is generally not included unless otherwise stated.
References NKR; kanker.nl
Additional remarks In 2016 werden er 28 diagnoses gesteld van wekedelensarcomen van overige en ongespecificeerde lokalisaties. Volgens kanker.nl is de incidentie per jaar 2-3 patiënten per miljoen inwoners (34-51 in Nederland).

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.