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Fedratinib

Extended indication Myelofibrosis
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance Fedratinib
Domain Oncology and Hematology
Main indication Other hematology
Extended indication Myelofibrosis
Manufacturer celgene
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)
Additional remarks JAK2 inhibitor

Registration

Registration route Centralised (EMA)
Particularity New medicine
Expected Registration January 2020
Registration phase Clinical trials
Additional remarks In 2013 zijn de klinische studies door Sanofi stopgezet wegens ernstige bijwerkingen (Wernicke’s encephalopathie). Celgene heeft Federatinib nu opgekocht.

Therapeutic value

Therapeutic value No judgement
Frequency of administration 1 times a day
Dosage per administration 400 mg
References NCT01437787

Expected patient volume per year

Patient volume

20 - 143

Market share is generally not included unless otherwise stated.
References NKR
Additional remarks 143 diagnoses in 2016. De inschatting van de werkgroep is 20 patiënten.

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

Indication extension Yes
Indication extensions Polycythemia Vera
References Fabrikant

Other information

There is currently no futher information available.